Atrial Fibrillation (AF)CRAAFT-HFNCT06505798
Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
A study testing Catheter Ablation in people with Atrial Fibrillation (AF), run by University College, London at 24 sites in 2 countries.
Trial summary
Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF). Treatments include drugs to slow the heart rate, anti-arrhythmic drugs or ablation of the heart to help preserve normal rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 21 Nov 2024to 15 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years.
- Patient is willing and able to give informed consent for participation.
- Able and willing to comply with all study requirements, including ability to participate in study for 12 months.
- Willing to allow their General Practitioner (GP) to be notified of participation in the study.
- Patient with one of the following AF categories and at least one episode of AF documented (by any means eg ECG, Holter, Cardiac Implantable Electronic Device (CIED) interrogation or any other means):
- Paroxysmal AF defined as spontaneous self-terminating AF lasted > 6 hours and <7 days.
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- Persistent AF as defined by at least one episode of AF >7 days but not >3 years (since 1st documentation)
- Optimal tolerated medical therapy for HF (including ACE-I (or ARB or ARNi), beta-blocker, SGLT2 inhibitor and mineralocorticoid receptor antagonist (MRA) and cardiac resynchronisation therapy (CRT) where indicated \& tolerated) for at least 6 weeks (according to the most contemporary European Society of Cardiology (ESC) HF guidelines). Maximal doses of these drugs are not mandated.
- New York Heart Association Classification (NYHA) class II to III
- LVEF <50% (Cardiac imaging report of LVEF<50% within 1 year (by echocardiography, cardiac magnetic resonance imaging or nuclear cardiology assessment)) AND after optimisation of medical therapy (see previous definition). Note - a LVEF of <50% must be documented by any cardiac imaging performed after optimisation of medical therapy. Documentation of other baseline echocardiographic parameters (eg LA volume, E/E' etc can be obtained from any echocardiogram within 2.5 years). This allows a handheld or echocardiogram focused on LVEF assessment.
- For those with LVEF 41-49% and without ongoing atrial fibrillation/flutter, N-terminal pro B-type natriuretic peptide (NT-proBNP) of ≥300pg/mL is required within 12 months prior to randomisation.
- For those with LVEF 41-49% and with ongoing atrial fibrillation/flutter, NTproBNP of ≥600pg/mL is required within 12 months prior randomisation.
- For those with LVEF ≤40%, NTproBNP is not required
Who cannot join
- Long standing (>3 year) persistent or permanent AF.
- Previous atrioventricular (AV) nodal ablation.
- Previous pulmonary vein isolation (PVI) or surgical ablation.
- Recent (<90 days) (type 1 spontaneous) myocardial infarction (type 2 myocardial infarctions are not an exclusion criterion), percutaneous coronary intervention, coronary artery bypass grafting, cardiac resynchronisation therapy or stroke.
- Severe aortic or pulmonary valve disease.
- Severe primary or secondary mitral valve regurgitation.
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- Active illness (other than HF) likely to result in death within 2 years.
- People who are pregnant or planning to become pregnant during the trial.
- People who are breastfeeding.
- Known allergy to contrast.
- Contraindication for PVI.
- Other conditions that may prevent subjects from adhering to the trial protocol, in the opinion of the investigator.
- Currently participating in another randomised controlled trial of another drug or medical device.
Trial locations and contacts
24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
CRAAFT-HF Team @ Barts CVCTU contact
24 sites in 2 countries
United Kingdom23 sites, 23 recruiting
- Recruiting
Mid and South Essex NHS Foundation Trust
Basildon
Sophie Harris, 01268 524900 ext. 6712, sophie.harris56@nhs.net
Neil Srinivasan
- Recruiting
Queen Elizabeth Hospital
Birmingham
Annette Nilsson, Annette.Nilsson@uhb.nhs.uk
Manish Kalla
- Recruiting
Blackpool Victoria Hospital
Blackpool
Natalie Irvine, natalie.irvine3@nhs.net
Alison Seed
- Recruiting
University Hospitals Dorset NHS Foundation Trust
Bournemouth
Becky Troke, 0300 0194514, becky.troke@uhd.nhs.uk
Richard Balasubramaniam
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0AY
Niina Ala-Krekola, 01223 639042, niina.ala-krekola@nhs.net
Claire Martin
- Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
Abeesh Sadasiva Panicker, 024 7696 7668 ext. 27668, abeeshsadasiva.panicker@uhcw.nhs.uk
Tarv Dhanjal
- Recruiting
Golden Jubilee National Hospital
Glasgow, G81 4DY
Linda Cassidy, 0141 951 5490, linda.cassidy@gjnh.scot.nhs.uk
Roy Gardner
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull
Jeanne Bulemfu, 07800726002, jeanne.bulemfu@nhs.net
Andrew Clark
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Lucy Leese, 0113 3923131, l.leese@nhs.net
Muzahir Tayebjee
- Recruiting
Glenfield Hospital
Leicester
Judith Fisher, Judith.fisher6@nhs.net
Louise Clayton
- Recruiting
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
Rajiv Sankaranarayanan
- Recruiting
Royal Brompton and Harefields Hospitals
London, UB9 6JH
Myra Brigoli, 01895 823 737, myra.brigoli1@nhs.net
Shouvik Haldar
- Recruiting
Barts Health NHS Trust
London
Flavia Pereira, 0, flavia.pereira1@nhs.net
Shohreh Honarbakhsh
- Recruiting
Imperial College Healthcare NHS Trust
London
Aisha Abdi, 0, aisha.abdi4@nhs.net
Prapa Kanagaratnam
- Recruiting
St George's University Hospitals NHS Foundation Trust
London
Zainab Ahmed, 020 8725 1029, zahmed@sgul.ac.uk
Mark Gallagher
- Recruiting
St Thomas' hospital
London
Olivia Fox, olivia.fox2@nhs.net
Aldo Rinaldi
- Recruiting
James Cook University Hosptial
Middlesbrough
Ben Ward, ben.ward8@nhs.net
Andrew Thornley
- Recruiting
Freeman Hospital, Royal Victoria Infirmary
Newcastle
Claire McMillan, claire.mcmillan4@nhs.net
Moloy Das
- Recruiting
Nottingham University Hospital NHS Trust
Nottingham
Jane Quinn, 0115 9691169 ext. 77460, Jane.Quinn7@nhs.net
Shahnaz Jamil-Copley
- Recruiting
University Hospitals Plymouth NHS Trust
Plymouth
Lorraine Madziva, 0, lorraine.madziva1@nhs.net
Sharon Man
- Recruiting
Queen Alexandra Hospital
Portsmouth
Serene Howe, Serena.howe1@nhs.net
Senthil Kirubakaran
- Recruiting
Southampton General
Southampton
Elizabeth Greenwood, elizabeth.greenwood@uhs.nhs.uk
John Paisey
- Recruiting
Swansea Bay University Health Board
Swansea
Debbie Williams, debbie.williams8@wales.nhs.uk
Dewi M Thomas
Canada1 site, 1 recruiting
- Recruiting
Halifax Infirmary
Halifax
Stephanie Hobbs, stephanie.hobbs@nshealth.ca
Aileen Davis, aileen.davis@nshealth.ca
About this study
Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF). Treatments include drugs to slow the heart rate, anti-arrhythmic drugs or ablation of the heart to help preserve normal rhythm. A number of trials have suggested that ablation may be superior to drug treatment to reduce hospitalisations or prevent early death. However, these studies have been small and the results not applicable to the general population with AF and heart failure in the UK. This international study will compare catheter ablation and optimal medical therapy versus optimal medical therapy alone to see if catheter ablation reduces unplanned heart failure hospitalisations and death rates and improves quality of life.
Read the detailed description
Atrial fibrillation (AF) increases the severity of, and death from, heart failure (HF). Several small studies have demonstrated that restoration of sinus rhythm by catheter ablation in patients with HF improves left ventricular (LV) function and exercise tolerance. What is unknown is whether or not AF ablation reduces all-cause death and urgent CV hospitalisations in populations with HF. The current trial will answer this outstanding question, which is faced by HF clinicians and electrophysiologists on a daily basis. AF ablation can be performed very effectively and efficiently using a cryo-balloon or radio-frequency ablation PVI technique. These techniques have evolved slowly and are unlikely to change substantially over the course of this trial. One small trial (n=363) in implantable cardioverter-defibrillator and CRT defibrillator recipients (CASTLE-AF) reported a death benefit of AF ablation but the patients were highly selected and the death reduction was far higher than real world expected differences. Recent studies have noted that the population randomised in CASTLE-AF was not representative of the general HF population with only 7% of patients in the "real world" setting meeting the trial entry criteria. CASTLE-AF is therefore provocative but inconclusive; it has made little change to clinical practice. As no studies have investigated the death benefit in a general HF population, the proposed trial is necessary and warranted. This study is designed as a randomised, open label multicentre clinical trial in which catheter ablation and medical therapy is compared to medical therapy alone in patients with HF with reduced ejection fraction (<50%) and paroxysmal or persistent AF to determine if this reduces all-cause death and urgent CV hospitalisations as well as improving QoL. By utilising the clinical and research networks of the British Heart Failure Society and British Heart Rhythm Society (BHRS) we will recruit 1200 patients. The current trial will be almost three times the size of the only previous inconclusive trial which was reported in the New England Journal of Medicine.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Catheter Ablation
- Keywords
- AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
Participants randomised to the catheter ablation arm will undergo Pulmonary Vein Isolation (PVI) which is the essential ablation intervention. The technique used will be at the discretion of the treating physician but may include Cryoballoon (Medtronic/Boston Scientific), Radiofrequency: CARTO (Biosense), pulsed field radiofrequency ablation, or Precision (Abbott Medical) electro-anatomical mapping systems. Additional ablation lesions may be delivered as preferred by the operator and will be documented. Electro-anatomical voltage maps will be collected (in SR/AF) and stored for later analysis.
| Study group | Role | What they receive |
|---|---|---|
| The optimal medical therapy as per standard of care | No intervention | Participants randomised to the optimal medical therapy arm will receive optimal medical therapy according to the most contemporary ESC HF guidelines. |
| The catheter ablation | Other | Catheter ablation is an established therapeutic strategy in patients without HF that aims to convert AF to sinus rhythm in symptomatic, drug-refractory AF in patients. Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first all-cause death and urgent CV hospitalisation
The primary outcome (time to first all-cause death and urgent CV hospitalisation) will be summarised by randomised group and analysed using a Cox proportional hazards regression model for time to first event, adjusting for factors used to balance the randomisation.
Measured: 2 years minimum (range: 2-5.5 years)
Secondary outcomes (5)
Total (first and recurrent) all-cause death and urgent cardiovascular hospitalisations.
Total (first and recurrent) number of all-cause deaths and urgent cardiovascular-related hospitalisations. Joint frailty models will be used to analyse time to death and recurrent urgent CV hospitalisations simultaneously. Additionally, negative binomial regression will be used to analyse the number of recurrent urgent CV hospitalisations.
Measured: 2 years minimum (range: 2-5.5 years)
QoL at 6 and 12 months assessed using the KCCQ-CSS.
Quality of Life (QoL) at 6 and 12 months assessed using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). Linear mixed effects regression models will be used to analyse repeated measurements of QoL. Scored from 0- 100, with a higher score indicating better health.
Measured: 12 months
Time to all-cause death
Time to all-cause death will be analysed using Cox proportional hazards regression model for time to event, matching the primary outcome.
Measured: 2 years minimum (range: 2-5.5 years)
Total (first and recurrent) all-cause death and urgent HF hospitalisations
Total (first and recurrent) number of all-cause deaths and urgent heart failure-related hospitalisations. Joint frailty models will be used to analyse time to death and recurrent urgent HF hospitalisations simultaneously. Additionally, negative binomial regression will be used to analyse the number of recurrent urgent HF hospitalisations.
Measured: 2 years minimum (range: 2-5.5 years)
Cardiovascular death
Total number of cardiovascular-related deaths. Cox proportional hazards regression model for time to event, matching the primary outcome.
Measured: 2 years minimum (range: 2-5.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start21 Nov 2024
- Primary completion15 Dec 2031 (estimated)
- Study completion15 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised, adaptive open label multicentre clinical trial which compares optimal medical therapy (as per standard of care) with catheter ablation plus optimal medical therapy alone in participants with HfrEF (LVEF\<50%) and paroxysmal or persistent atrial fibrillation. This design is adaptive in that the required sample size is reviewed in an interim analysis at 80% recruitment. This interim analysis aims to ensure that sufficient patients are recruited to maintain the conditional power of the study at 80% or higher. Options which can be deployed at the interim analysis include increasing patient numbers and increasing duration of follow up.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Lambiase, Principal investigator, University College, LondonMark Petrie, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505798
- Sponsor's protocol ID
- 136905
- Other IDs
- CS/F/21/190034 CRAAFT-HF, 281142, 24/LO/0301
- Acronym
- CRAAFT-HF
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
- ClinicalTrials.gov ID
- NCT06505798
- Acronym / sponsor ID
- CRAAFT-HF / 136905
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- AF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 15 Dec 2031 (estimated)
- Study completion
- 15 Dec 2031 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is a common heart rhythm disorder that causes an irregular heart beat and is a cause of heart failure (HF). Treatments include drugs to slow the heart rate, anti-arrhythmic drugs or ablation of the heart to help preserve normal rhythm. A number of trials have suggested that ablation may be superior to drug treatment to reduce hospitalisations or prevent early death. However, these studies have been small and the results not applicable to the general population with AF and heart failure in the UK. This international study will compare catheter ablation and optimal medical therapy versus optimal medical therapy alone to see if catheter ablation reduces unplanned heart failure hospitalisations and death rates and improves quality of life.
Detailed description
Atrial fibrillation (AF) increases the severity of, and death from, heart failure (HF). Several small studies have demonstrated that restoration of sinus rhythm by catheter ablation in patients with HF improves left ventricular (LV) function and exercise tolerance. What is unknown is whether or not AF ablation reduces all-cause death and urgent CV hospitalisations in populations with HF. The current trial will answer this outstanding question, which is faced by HF clinicians and electrophysiologists on a daily basis. AF ablation can be performed very effectively and efficiently using a cryo-balloon or radio-frequency ablation PVI technique. These techniques have evolved slowly and are unlikely to change substantially over the course of this trial. One small trial (n=363) in implantable cardioverter-defibrillator and CRT defibrillator recipients (CASTLE-AF) reported a death benefit of AF ablation but the patients were highly selected and the death reduction was far higher than real world expected differences. Recent studies have noted that the population randomised in CASTLE-AF was not representative of the general HF population with only 7% of patients in the "real world" setting meeting the trial entry criteria. CASTLE-AF is therefore provocative but inconclusive; it has made little change to clinical practice. As no studies have investigated the death benefit in a general HF population, the proposed trial is necessary and warranted. This study is designed as a randomised, open label multicentre clinical trial in which catheter ablation and medical therapy is compared to medical therapy alone in patients with HF with reduced ejection fraction (<50%) and paroxysmal or persistent AF to determine if this reduces all-cause death and urgent CV hospitalisations as well as improving QoL. By utilising the clinical and research networks of the British Heart Failure Society and British Heart Rhythm Society (BHRS) we will recruit 1200 patients. The current trial will be almost three times the size of the only previous inconclusive trial which was reported in the New England Journal of Medicine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised, adaptive open label multicentre clinical trial which compares optimal medical therapy (as per standard of care) with catheter ablation plus optimal medical therapy alone in participants with HfrEF (LVEF<50%) and paroxysmal or persistent atrial fibrillation. This design is adaptive in that the required sample size is reviewed in an interim analysis at 80% recruitment. This interim analysis aims to ensure that sufficient patients are recruited to maintain the conditional power of the study at 80% or higher. Options which can be deployed at the interim analysis include increasing patient numbers and increasing duration of follow up.
| Arm | Type | Receives |
|---|---|---|
| The optimal medical therapy as per standard of care | No intervention | –Participants randomised to the optimal medical therapy arm will receive optimal medical therapy according to the most contemporary ESC HF guidelines. |
| The catheter ablation | Other | Procedure: Catheter AblationCatheter ablation is an established therapeutic strategy in patients without HF that aims to convert AF to sinus rhythm in symptomatic, drug-refractory AF in patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients aged ≥18 years.
- Patient is willing and able to give informed consent for participation.
- Able and willing to comply with all study requirements, including ability to participate in study for 12 months.
- Willing to allow their General Practitioner (GP) to be notified of participation in the study.
- Patient with one of the following AF categories and at least one episode of AF documented (by any means eg ECG, Holter, Cardiac Implantable Electronic Device (CIED) interrogation or any other means):
Key exclusion criteria (13 listed)
- Long standing (>3 year) persistent or permanent AF.
- Previous atrioventricular (AV) nodal ablation.
- Previous pulmonary vein isolation (PVI) or surgical ablation.
- Recent (<90 days) (type 1 spontaneous) myocardial infarction (type 2 myocardial infarctions are not an exclusion criterion), percutaneous coronary intervention, coronary artery bypass grafting, cardiac resynchronisation therapy or stroke.
- Severe aortic or pulmonary valve disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter AblationParticipants randomised to the catheter ablation arm will undergo Pulmonary Vein Isolation (PVI) which is the essential ablation intervention. The technique used will be at the discretion of the treating physician but may include Cryoballoon (Medtronic/Boston Scientific), Radiofrequency: CARTO (Biosense), pulsed field radiofrequency ablation, or Precision (Abbott Medical) electro-anatomical mapping systems. Additional ablation lesions may be delivered as preferred by the operator and will be documented. Electro-anatomical voltage maps will be collected (in SR/AF) and stored for later analysis. | Procedure or surgery | The catheter ablation |
Primary outcome
Time to first all-cause death and urgent CV hospitalisation
Time frame: 2 years minimum (range: 2-5.5 years)
The primary outcome (time to first all-cause death and urgent CV hospitalisation) will be summarised by randomised group and analysed using a Cox proportional hazards regression model for time to first event, adjusting for factors used to balance the randomisation.
5 secondary outcomes
Total (first and recurrent) all-cause death and urgent cardiovascular hospitalisations.
Time frame: 2 years minimum (range: 2-5.5 years)
QoL at 6 and 12 months assessed using the KCCQ-CSS.
Time frame: 12 months
Time to all-cause death
Time frame: 2 years minimum (range: 2-5.5 years)
Total (first and recurrent) all-cause death and urgent HF hospitalisations
Time frame: 2 years minimum (range: 2-5.5 years)
Cardiovascular death
Time frame: 2 years minimum (range: 2-5.5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CRAAFT-HF Team @ Barts CVCTU contact
Pier Lambiase principal investigator
University College, London
Mark Petrie principal investigator
University of Glasgow
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Ablation in people with Atrial Fibrillation (AF), run by University College, London at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Lambiase (07977217787, p.lambiase@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first all-cause death and urgent CV hospitalisation (time frame: 2 years minimum (range: 2-5.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.