Combining pulmonary vein isolation and left atrial appendage closure for atrial fibrillation treatment
COnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Asklepios proresearch Industry-sponsored |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT06861673 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with non-valvular atrial fibrillation at high risk for stroke who are ineligible for long-term oral anticoagulation.
Not a fit: Patients who are not eligible for either pulmonary vein isolation or left atrial appendage closure will not benefit from this study.
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 performed: Previous studies have shown success with similar combined approaches, indicating potential for this novel method.
Eligibility criteria
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 this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- Asklepios Klinik Altona — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
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.