Comparing cardioversion and ablation for persistent atrial fibrillation
Objective Randomised Blinded Investigation of Cardioversion Versus Ablation for Persistent Atrial Fibrillation (ORBICA-AF)
NA · Barts & The London NHS Trust · NCT06096246
This study is testing whether a heart procedure called catheter ablation works better than a shock treatment to keep people with persistent atrial fibrillation from having their heart rhythm go out of sync again.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Barts & The London NHS Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06096246 on ClinicalTrials.gov |
What this trial studies
This research investigates whether pulmonary vein isolation through catheter ablation leads to lower rates of atrial fibrillation (AF) recurrence compared to direct current (DC) cardioversion in patients with persistent AF. The study will involve a blinded, randomized trial design to compare the effectiveness of these two treatment strategies. Patients will be monitored for AF recurrence and other outcomes following their assigned treatment. The trial aims to provide clarity on the optimal first-line treatment for persistent AF, which has not been established in previous studies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with persistent atrial fibrillation lasting more than 7 days and less than 2 years.
Not a fit: Patients with severe renal impairment, uncontrolled hypertension, or contraindications for anticoagulation or catheter ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with persistent atrial fibrillation, potentially reducing recurrence rates.
How similar studies have performed: This approach is novel as no previous blinded randomized controlled trials have compared early-ablation strategies to cardioversion-led strategies for persistent AF.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to give informed consent * Age 18-85 years * Persistent AF (atrial fibrillation lasting \> 7days) of total continuous duration \<2 years as documented in medical notes. * Patients being considered for cardioversion. Exclusion Criteria: * Creatinine clearance (eGFR) \< 30mls/min * Contraindication or unable to take anticoagulation * Uncontrolled hypertension * Contraindication for catheter ablation * BMI \> 40 * Patients in Persistent AF who have had more than one previous cardioversion. * Established diagnosis of Hypertrophic cardiomyopathy
Where this trial is running
London
- Barts Heart Centre — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Malcolm Finlay — Barts & The London NHS Trust
- Study coordinator: Malcolm Finlay, FRCP PhD
- Email: malcolm.finlay1@nhs.net
- Phone: 02037658635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Atrial Fibrillation, Cardiac Arrhythmia, Catheter Ablation