As one of the largest cardiovascular (heart and blood vessels) specialist centres in the UK, we carry out lots of different research. This includes new surgical treatments, and better ways to manage disturbances in heart rhythm (known as arrhythmias).
Find out how imaging is transforming care for cardiac patients
At Guy's and St Thomas’ cardiologists are working to improve the way they use imaging to diagnose and treat patients with cardiac disorders.
Read about past studies. Please note we are no longer recruiting volunteers for these trials.
Valvular heart disease
Novel percutaneous techniques for percutaneous treatment of mitral regurgitation
Title: Novel percutaneous techniques for percutaneous treatment of mitral regurgitation in subjects unsuitable for conventional cardiac surgery.
Guy's and St Thomas’ is one of the world’s leading institutions for the delivery of percutaneous valve interventions and undertook the first human transcatheter mitral valve implantations in 2014. The team are now leading several international collaborative studies exploring innovative techniques for percutaneous mitral annular placation and mitral valve implantation using both existing devices designed for use in the aortic position (Edwards S3 Boston Lotus) or novel device designs (MvRx MAVERIC and Medtronic Twelve).
Investigators: Simon Redwood, Bernard Prendergast, Ronak Rajani, Jane Hancock, Vinnie Bapat.
Collaborations on transcatheter technologies for patients with severe aortic stenosis
Title: International collaborations on novel transcatheter technologies for patients with severe aortic stenosis (the Respond and SAVI Registries).
Post-market surveillance registries for the SYMETIS ACURATE neo Aortic Bioprosthesis, the ACURATE TF Transfemoral Delivery System and the Boston Scientific Lotus transcatheter heart valve for patients with severe aortic stenosis who are at high risk for conventional open AVR. The objective of the studies is to collect real world clinical, safety and device performance outcomes (1000 patients per study). All patients will be followed up for five years.
Investigators: Bernard Prendergast, Jane Hancock, Karen Wilson, Chris Young, Vinnie Bapat, Simon Redwood.
Service evaluation for infective endocarditis
Title: Service evaluation for infective endocarditis.
This department service evaluation is to establish the relapse rate of infective endocarditis in patients who have been treated surgically at the cardiovascular centre over a 10 year period. In the past, the practice has been to use abbreviated post-operative antibiotic courses. This service evaluation may provide evidence that the duration of recommended antibiotic courses as stated in the current guidelines may be excessive.
In order to complete the service evaluation, patients who fall under the criteria have been identified and patient identifiers, including NHS number, gender, postcode and date of birth are disclosed to the Health and Social Care Information Centre (HSCIC) so that the HSCIC can link those identifiers to the Hospital Episode Database (HES) and provide a file back to the centre which contains the identifying information together with the hospital episode information from databases held by the HSCIC. It may be necessary for us to contact the Consultant responsible for the care episode to discuss and clarify diagnosis should, and only if, a HES suggest a possible episode of IE. The data received then has the identifiers removed so that the analysis can be conducted on a pseudonymised dataset which protects patient confidentiality.
Any patients who do not wish for their data to be used in this way can easily opt out of the analysis by contacting the centre on 020 7188 1047 (Professor John Chambers) or by emailing the centre on email@example.com.
Comparison of the Toronto stentless and
Perimount stented biological aortic replacement valve
Title: A randomised long-term comparison of the Toronto stentless and Perimount stented biological aortic replacement valve.
Stentless valves were introduced with the expectation of better haemodynamic function, and durability with lower event rates. This is a prospective randomised trial begun in 1994 to compare long-term clinical events and failure rates with two different classes of replacement aortic valve. Early results showed no difference in haemodynamic function.
Investigators: Denise Parkin, Christopher Blauth, John Chambers.
Comparison of the Mosaic porcine and Perimount pericardial stented biological replacement aortic valves
Title: A comparison of failure rates in the Mosaic porcine and Perimount pericardial stented biological replacement aortic valves.
Anecdotal evidence suggests that the Mosaic valve has higher than expected rates of early structural deterioration. This is a case-matched comparison with an industry-standard.
Investigators: Denise Parkin, Jess Webb, John Chambers.
Methods of improving the community detection of heart valve disease
Title: Methods of improving the community detection of heart valve disease
Heart valve disease is often undetected and the key lies in the community. This is a programme investigating: the effect of devolved sonographer-led services; quick-scans as a screening mechanism; and intelligent software.
Chief UK investigator: CA Rinaldi.
Infective endocarditis after valve replacement
Title: Infective endocarditis after valve replacement: data linkage studies to determine outcomes after surgical and transcatheter valve implantation and the impact of NICE 2008 guidelines on prosthetic valve endocarditis.
This retrospective observational cohort study will link “big data” from NICOR (National Audit of Adult Cardiac Surgery and TAVI registry) and Hospital Episode Statistics (HES) to determine whether prosthetic valve endocarditis is more common after TAVI or SAVR and more frequent since radical changes in antibiotic prophylaxis guidelines instigated by NICE in 2008. Both questions are of major international relevance and can only be answered using unique NHS data.
Investigators: Simon Redwood, Tom Cahill, Bernard Prendergast.
The HeArt ValvE Clinic International Database
(The HAVEC registry)
Title: The HeArt ValvE Clinic International Database (The HAVEC registry).
This is an international multicentre observational investigation of the safety of conservative management in patients with severe aortic stenosis or degenerative mitral regurgitation.
Investigators: John Chambers, Magdalena Garbi, Raphael Rosenhek, Philippe Pibarot, Catherine Otto, Luc Piérard Patrizio Lancellotti.
Prevention of aortic stenosis pilot trial
Title: Prevention of aortic stenosis pilot trial.
This is a two-centre feasibility study of the use of sevelamer to lower phosphate levels in patients with early aortic stenosis.
Investigators: David Wald, John Chambers.
Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON)
Title: Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON).
This study includes patients requiring a surgical aortic valve replacement. The purpose of the study is to evaluate the safety and effectiveness of a new bovine pericardial stented aortic bioprosthesis from Medtronic. The collected data will be used to support regulatory applications in seeking market approval for the valve in Europe (CE Mark), the United States, Canada and other geographies.
Investigators: Vinayat Bapat, Francesco Pirone.
Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3 Trial (FAME 3)
Title: Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3 Trial (FAME 3).
The FAME 3 trial is a multicenter, international, randomised, controlled non-inferiority trial, looking at the treatment of multi vessel coronary artery disease. The study is a comparison of Fractional Flow Reserve-Guided (FFR) Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG) Surgery in Patients with Multivessel Coronary Artery Disease.
Investigators: Simon Redwood, Chris Young.
Effects of Remote Ischaemic Conditioning
Title: Effects of Remote Ischaemic Conditioning on clinical outcomes in ST segment elevation myocardial infarction patients undergoing Primary Percutaneous Coronary Intervention (ERIC PPCI).
In patients presenting with an ST-elevation myocardial infarction (STEMI), early myocardial reperfusion using primary percutaneous coronary intervention (PPCI) is the most effective therapeutic intervention for limiting myocardial infarct (MI) size, a major determinant of prognosis post-PPCI. However, despite PPCI, the morbidity and mortality of STEMI patients remain significant, paving the way for novel therapeutic strategies for protecting the heart against acute ischaemia-reperfusion injury (IRI). In this respect, remote ischaemic conditioning (RIC) represents a non-invasive and low cost therapeutic strategy for further reducing MI size, preventing the onset of heart failure, and improving clinical outcomes in PPCI patients.
Investigators: Simon Redwood, Divaka Perera, James Coutts, Brian Clapp, Bernard Prendergast, Antonis Pavlidis.
REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED-BCIS 2)
Title: REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED-BCIS 2).
This study is looking at patients with ischaemic cardiomyopathy. Previous studies have demonstrated that those with viable myocardium have a strong survival advantage following revascularisation compared to medical therapy alone. This multicentre prospective randomised open controlled trial aims to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) combined with optimal medical therapy (OMT) compared to OMT alone for ischaemic cardiomyopathy and viable myocardium.
Investigators: Divaka Perera, Simon Redwood, Gerry Carr-White.
Optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) – the GALILEO study
Title: Optimal antithrombotic therapy after transcatheter aortic valve implantation (TAVI) – the GALILEO study.
Stroke and other thromboembolic syndromes are feared complications of TAVI and the optimal regime of post-procedural antithrombotic therapy is unknown. In this large international multicentre randomised controlled trial, investigators at St Thomas’ are working with collaborators around the world to explore the role of the direct Factor Xa inhibitor, rivaroxaban, as an anticoagulation-based treatment strategy to reduce thromboembolic complications following successful TAVI.
Investigators: Simon Redwood, Jane Hancock, Karen Wilson, Bernard Prendergast.
Comparing transcatheter aortic valve implantation (TAVI) and conventional aortic valve replacement
Title: A randomised controlled trial comparing transcatheter aortic valve implantation (TAVI) and conventional aortic valve replacement in intermediate risk subjects (UK TAVI).
Although TAVI is an established treatment option for inoperable subjects with symptomatic severe aortic stenosis and an alternative to open heart surgery in high risk subjects, its role in intermediate and low risk subjects is unclear. The St Thomas’ TAVI team is playing a leading role in this UK-wide randomised trial supported by the UK HTA which will guide international practice in this controversial area.
Investigators: Simon Redwood, Jane Hancock, Chris Young, Bernard Prendergast.
Investigation of the haemodynamic and
physiological principles of patients with aortic stenosis
Title: Investigations of the haemodynamic and physiological principles underlying paradoxical low flow-low gradient aortic stenosis in subjects undergoing transcatheter aortic valve implantation (TAVI).
TAVI is a transformative treatment for aortic stenosis (AS). However, there is a subgroup of patients who are unable to generate high velocities of blood flow across their narrowed aortic valves (so called low flow-low gradient AS) in whom the benefit of intervention is diminished. Using detailed invasive protocols established at St Thomas’ Hospital to examine the interaction of coronary flow and left ventricular pressure-volume relationships, we will assess the potential contribution of microvascular ischaemia to this condition and, by detailed characterisation of the low-flow aortic stenosis phenomenon, hope to identify early features of left ventricular decompensation which will allow optimal timing of intervention and guide future research into alternative therapeutic strategies.
Investigators: Bernard Prendergast, Hannah McConkey, Simon Redwood.
Optimal treatment of coronary artery disease in patients with aortic stenosis undergoing TAVI (The ACTIVATION Trial)
Title: Optimal treatment of coronary artery disease in patients with aortic stenosis undergoing TAVI (The ACTIVATION Trial).
Coronary artery disease is common in patients with aortic stenosis but its clinical importance is unclear, particularly in the elderly cohort who present for TAVI. This multicentre randomised controlled trial (led by St Thomas’) will compare strategies of conservative management versus stenting in this high risk patient group..
Investigators: Bernard Prendergast, Jane Hancock, Simon Redwood.
AMPLATZER Amulet Observational Post-Market
Title: AMPLATZER Amulet Observational Post-Market Study.
St Thomas’ Hospital are taking part in this prospective, multicentre, observational, non-randomised study looking at the use if the AMPLATZER Amulet Appendage Left Atrial Appendage Occluder. The Amulet device is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA in patients with persistent or permanent Atrial Fibrillation (AF). The purpose of the Amulet observational post-market study is to compile real world outcome data on the use of the CE marked Amulet device in NVAF subjects.
Investigators: Brian Clapp, Jas Gill, Stam Kapetanakis.
Cardiac resynchronisation therapy
RADI-CRT: Pressure Wire Guided Cardiac Resynchronisation Therapy
Title: RADI-CRT: Pressure Wire Guided Cardiac Resynchronisation Therapy.
An international clinical trial looking at hemodynamic guided CRT recruiting 280 patients in the UK & Italy. (ClinicalTrials.gov Identifier: NCT01464502). This study which is finishing recruitment and will be the largest multi-centre study of haemodynamic guidance for CRT and will inform CRT guidance.
Chief investigator: CA Rinaldi.
ELECTRA European Lead extraction Controlled Registry on the practice of lead extraction
Title: ELECTRA European Lead extraction Controlled Registry on the practice of lead extraction.
This is the largest lead extraction study in over 3000 patients in Europe and will provide information on the practice of lead extraction. Guy's and St Thomas' was the UK site for this study. The study has finished recruitment and is awaiting publication.
UK chief investigators: CA Rinaldi.
Standard care versus triventricular pacing in heart failure (STRIVE HF)
Title: Standard care versus triventricular pacing in heart failure (STRIVE HF).
A multicentre randomised control trial comparing standard cardiac resynchronisation pacing with triventricular pacing, which will demonstrate the efficacy of this novel pacing strategy. Recruitment underway and will include 10 UK centres.
Chief investigators: CA Rinaldi.
Pro MRI study
Title: Pro MRI study.
A multi-national study in collaboration with Biotronik Corp looking at use of MRI compatible pacemakers, which recently completed recruitment of 100 patients in over 10 European sites. (ClinicalTrials.gov Identifier: NCT01460992).
Chief UK investigator: CA Rinaldi.
Title: iSPOT study.
An international study of multisite pacing in the UK, Belgium and Israel. (ClinicalTrials.gov Identifier: NCT01883141).
Investigators: CA Rinaldi.
MOre REsponse on Cardiac Resynchronisation Therapy with MultiPoint Pacing (MORE-CRT MPP)
Title: MOre REsponse on Cardiac Resynchronisation Therapy with MultiPoint Pacing (MORE-CRT MPP).
This prospective, randomised, multi-centre trial will assess the impact of the multi point pacing feature at 12 months in the treatment of patients not responding to standard cardiac resynchronisation therapy after six months
Investigators: Aldo Rinaldi, Jas Gill, Mike Cooklin, Matt Wright, Shoaib Hamid, Paresh Metha.
MultiPoint™ Pacing Mapping Study
Title: MultiPoint™ Pacing Mapping Study (MPP MAPPING).
Prospective, observational, 4-centre acute feasibility study with 6-month follow-up will characterise left ventricular acute hemodynamic and electrical responses during cardiac resynchronisation therapy with different MultiPoint™ pacing settings, and also assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.
Investigators: Aldo Rinaldi.
Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds (ENABLE MRI)
Title: Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds (ENABLE MRI).
A prospective, non-randomised, confirmatory, global study conducted as a post market study in Europe, Israel and Asia Pacific aimed at collecting data to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T MRI environment under the labelled Conditions of Use (Phase I). The study will also assess medically necessary MR scans according to the labelled Conditions of Use to provide real-world scanning data.
Investigators: Aldo Rinaldi.
WiCS-LV post market surveillance registry
Title: WiCS-LV post market surveillance registry (device registry for post market clinical follow-up of the WiCS-LV system under a process of controlled release onto the market).
An observational, prospective, non-randomised registry. Standard of care data will be collected for five years. The WiCS-LV system is an implantable cardiac pacing system capable of delivering pacing energy to the heart without using a pacing lead. The system provides endocardially delivered left ventricular stimulation as an alternative to the standard epicardial coronary sinus pacing lead stimulation for cardiac resynchronisation therapy.
Investigators: Aldo Rinaldi.
The role of early CT coronary angiography in
patients with acute coronary syndrome
Title: The role of early CT coronary angiography in the evaluation, intervention and outcome of patients presenting to the emergency department with suspected or confirmed acute coronary syndrome. RAPID CTA trial.
Coronary artery disease (CAD) occurs when narrowing develops in the blood vessels supplying the heart. If the blood vessels become blocked, the patient may develop a critical lack of blood and oxygen getting to the heart muscle or an acute coronary syndrome (ACS) and be at risk of a heart attack, heart failure and death. Computerised tomography coronary angiography (CTCA) involves using a CT scan to identify blockages in the coronary arteries. It is slightly less accurate at identifying obstruction than invasive coronary angiography but has much fewer risks. It could, therefore, be used to improve the investigation of medium-risk patients. Patients will be allocated to either receive CTCA as part of their assessment or receive standard assessment without this test. We will then follow up patients for one year to determine the rate of bad outcomes (such as heart attack or death), quality of life, patient satisfaction, the use of diagnostic tests or treatments, and health care costs.
Investigators: Ronak Rajani, Rebecca Preston, Arjun Nair, Laura Hunter.
Safety and efficacy of the Veniti Vici™
venous stent system
Title: Safety and efficacy of the Veniti Vici™ venous stent system (Veniti, Inc) when used to treat clinically significant chronic non-malignant obstruction of the Iliofemoral venous segment.
Prospective, multicenter, single arm, non-randomized study. The objective of this study is to assess the safety and efficacy of the Veniti Vici™ venous stent system in achieving patency of the target venous lesion through 36 months in patients who present with clinically significant chronic non-malignant obstruction of the iliofemoral venous outflow tract.
Investigators: Mr S Black.
Bypass vs Angioplasty in Severe Ischaemia of the Leg-2 trial: BASIL-2 trial
Title: Bypass vs. Angioplasty in Severe Ischaemia of the Leg-2 trial: BASIL-2 trial.
An individually randomised multi-centre two-arm open trial of two alternative revascularisation strategies (VB first vs. BET first) for the management of Severe Limb Ischaemia due to infra-popliteal, with or without femoro-popliteal, disease. To determine which strategy represents the most clinically and cost-effective treatment.
Investigators: Mr H Zayed.
Investigation into the pathophysiology of lower limb ischaemia and how to promote therapeutic revascularisation
Title: An investigation into the pathophysiology of lower limb ischaemia and how to promote therapeutic revascularisation in the critically ischaemic limb.
This programme of work concentrates on three areas:
i) To identify the distribution of important cells (from blood and/or muscle biopsies) (e.g. angiogenic monocytes) in patients with CLI and controls and compare the functional properties (in vitro and in vivo). ii) to develop novel MRI imaging methods to accurately quantify and map out tissue perfusion in ischaemic limbs. iii) To quantify the haemodynamic significance of arterial stenosis/occlusion and the collateral circulation in the lower limb of patients undergoing planned intra-arterial angiography/angioplasty with measurements of flow/pressure in the artery.
Investigators: Mr B Modarai, Mr A Patel, Dr Ludwinski.
Effective treatments for Thoracic Aortic
Aneurysms (ETTAA Study): a prospective cohort study
Title: Effective treatments for Thoracic Aortic Aneurysms (ETTAA Study): a prospective cohort study
A prospective, multi-centre, observational, cohort study. To follow patients with a chronic thoracic aortic aneurysm (CTAA) of the aortic arch or descending aorta 4cm or over. To quantify clinical outcomes in each treatment cohort (watchful waiting WW, best medical therapy BMT, endovascular stent grafting ESG and open surgical repair OSR) in terms of survival and quality of life. To identify patient-specific or aneurysm-specific features that might predict poor outcome in each treatment group by risk-modelling methods and to estimate the clinical- and cost-effectiveness of competing treatments to define optimal management strategies for patients in whom more than one treatment is considered appropriate.
Investigators: Miss R Bell.
The ROAM-CLI study: retention of angiogenic
CD16+ monocytes in critical limb ischaemia
Title: The ROAM-CLI study: retention of angiogenic CD16+ monocytes in critical limb ischaemia.
The overall aim of this study is to determine:
(i) whether it is feasible to isolate CD16+ monocytes from the peripheral blood of patients with CLI;
(ii) radiolabel and deliver these cells into the ischaemic limb; and
(iii) track these cells after delivery, using nuclear medicine imaging techniques, to determine the proportion of retained cells over time.
To examine the tissue retention of autologous CD16+ monocytes isolated from peripheral blood and then injected into the ischaemic limb.
Investigators: Mr Modarai, Mr A Patel.
Thrombosis and its resolution: mechanisms and imaging
Title: Thrombosis and its resolution: mechanisms and imaging.
To investigate whether MRI (alone or in conjunction with circulating biomarkers) can provide information relating thrombus structure to the susceptibility to lysis; or predict whether a thrombus is likely to resolve rapidly through natural processes.
The central aims of this programme of work are as follows:
(i) To investigate if novel MRI imaging methods can accurately quantify and characterise thrombosis in humans;
(ii) To investigate whether MRI has utility in stratifying patients who respond favourably to lysis;
(iii) To determine whether there are circulating biomarkers that relate to the structure of thrombosis as assessed by MRI.
A study of the mechanisms that give rise to
Title: A study of the mechanisms that give rise to vascular disease.
The study objective is to gain a better understanding of the mechanisms that give rise to and propagate arterial occlusion (plaque) or arterial dilatation (aneurysms) would facilitate the development of: therapies that prevent plaque or aneurysm development and progression; or biomarkers of disease progression. This may come from access to blood and samples of plaque or aneurysm wall (that are available and normally disposed of during surgery), from which we can analyse the cellular and molecular ‘fingerprints’ of these conditions.
Chief investigator: Professor Smith, principal investigator: Mr Modarai.
Markers of the susceptibility to aneurysm
formation and progression
Title: Markers of the susceptibility to aneurysm formation and progression.
The main study objectives are:
1. To elucidate inherited gene variants that predispose to aneurysmal disease using innovative exome or whole genome sequencing.
2. To search for biomarkers, in the plasma or serum of these subjects, that may be directly be measured to predict the presence or progression of aneurysmal disease or act as a putative imaging target that is informative of the likelihood of progression.
Chief investigator: Professor Smith; principal investigator: Mr Modarai.
Human studies in cardiovascular valve failure
Title: Human studies in cardiovascular valve failure.
To understand the processes controlling valve development in humans and how errors in these processes can lead to human disease: Are cardiac/venous/lymphatic valves or vessels abnormal in patients with a specific known genetic mutation?. Is a particular gene of interest expressed (made into a protein) in cardiac/venous/lymphatic valves? Are other molecules that affect gene function found in cardiac/venous/lymphatic valves or vessels? In patients with abnormal cardiac/venous/lymphatic valves, is there a genetic abnormality?
Chief investigator: Professor Smith; principal investigator: Mr Modarai, Mr O Lyons.
The role of adipose-derived stromal cells in lower
limb ischaemia. Can they promote therapeutic neovascularisation?
Title: An investigation into the role of adipose-derived stromal cells in lower limb ischaemia and whether they can promote therapeutic neovascularisation in patients with critically ischaemic limbs.
To identify novel, potent cell types (e.g. angiogenic adipose derived stem cells) as candidates for angiogenic cell therapy in patients with leg ischaemia. To compare the angiogenic potential of adipose derived stem cells (ASCs) isolated from the fat in the ischaemic leg with fat from the non-ischaemic leg, upper limb and abdomen.
Investigators: Mr B Modarai.