Combining pulmonary vein isolation and left atrial appendage closure for atrial fibrillation treatment
Official title: COnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study
Run by Asklepios proresearch · NCT06861673 · Data updated 2026-11-12
This study is testing if combining two procedures—one to isolate the pulmonary veins and another to close off a part of the heart—can help people with non-valvular atrial fibrillation who can't take blood thinners and are at high risk for stroke.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Asklepios proresearch Industry-sponsored |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | April 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT06861673 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with non-valvular atrial fibrillation at high risk for stroke who are ineligible for long-term oral anticoagulation.
✕Probably not a fit
Patients who are not eligible for either pulmonary vein isolation or left atrial appendage closure will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with non-valvular atrial fibrillation (AF) who are at high risk for stroke and cannot use long-term oral anticoagulation. It evaluates the safety, efficacy, and efficiency of a combined approach using pulsed field ablation (PFA) for pulmonary vein isolation (PVI) and left atrial appendage closure (LAAC) in a multicenter registry. The study aims to determine if this concomitant procedure can provide benefits over traditional methods, particularly in terms of reduced procedure times and enhanced safety profiles. The Farapulse PFA system is utilized, which has shown promising results in previous registries.
Why it matters
Potential benefit: If successful, this approach could offer a safer and more efficient treatment option for patients with atrial fibrillation who are at high stroke risk.
How similar studies have gone: Previous studies have shown success with similar combined approaches, indicating potential for this novel method.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Indicatio for PVI and LAAC Exclusion Criteria: Not eligible for any of the procedures PVI and LAAC
Where it's running
-
Asklepios Klinik Altona
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.