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Compares treatment options for Atrial Fibrillation (AF)
Official title Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
ClinicalTrials.gov ID: NCT06505798
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Severe aortic or pulmonary valve disease.
- Severe primary or secondary mitral valve regurgitation.
See the full eligibility criteria
- 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.
- 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 \&...
- 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...
- 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
- 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...
- Severe aortic or pulmonary valve disease.
- Severe primary or secondary mitral valve regurgitation.
- 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 people from adhering to the trial protocol, in the opinion of the investigator.
- Currently participating in another assigned by chance controlled trial of another drug or medical device.
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Canada
- Basildon, United Kingdom
- Birmingham, United Kingdom
- Blackpool, United Kingdom
- Bournemouth, United Kingdom
- Cambridge, United Kingdom
- Coventry, United Kingdom
- Glasgow, United Kingdom
- Hull, United Kingdom
- Leeds, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Middlesbrough, United Kingdom
- Newcastle, United Kingdom
- Nottingham, United Kingdom
- Plymouth, United Kingdom
- Portsmouth, United Kingdom
- Southampton, United Kingdom
- Swansea, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Canada; Basildon, United Kingdom; Birmingham, United Kingdom; Blackpool, United Kingdom; Bournemouth, United Kingdom; Cambridge, United Kingdom and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.