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COCONUT Study Concomitant PVI and LAAC

NCT06861673 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)

Interventions

DEVICE

Pulmonary vein isolation

concomitant PVI and LAAC

Sponsors & Collaborators

  • Asklepios proresearch

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-04-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06861673 on ClinicalTrials.gov