RecruitingNCT06861673

COCONUT Study Concomitant PVI and LAAC

COnCOmitaNt Pulse Field Ablation Based pUlmonary Vein Isolation and lefT Atrial Appendage Closure - The COCONUT Study

Sponsor

Asklepios proresearch

Enrollment

60 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation (AF)

Summary

In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and registries.8 While PVI and LAAC are both conducted in the left atrium and share the same access route, a combined concomitant approach might be beneficial for patients but is not conventionally practiced. Due to significantly shorter procedures times and high safety profile PFA based catheter ablation may be advantageous for the combined approach of PVI and LAAC. We are performing a word-wide, retrospective, multicenter registry study focusing on patients with concomitant Farapulse PFA based PVI and LAAC (WATCHMAN Flx, Boston Scientific). To evaluate safety, efficacy and efficiency in a multicenter study the COCONUT study was conducted.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is looking at the safety and outcomes of doing two heart procedures at the same time: pulmonary vein isolation (PVI, to treat an irregular heartbeat called atrial fibrillation) and left atrial appendage closure (LAAC, to reduce stroke risk by sealing off a small pouch in the heart). **You may be eligible if...** - You have a medical indication for both PVI (atrial fibrillation treatment) and LAAC (stroke prevention) **You may NOT be eligible if...** - You are not a candidate for one or both of these procedures based on your doctor's assessment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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