Concomitant PFA Bsaed PVI Plus LAAC (COCONUT_2)

March 11, 2026 updated by: Prof. Christian-Hendrik Heeger, Asklepios proresearch

Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study

A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific).

For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective is to invite high-volume centers in Germany to submit the procedural and periprocedural data, as well as the 12-months follow-up data in a secure and standardized way. In comparison to the most registries conducted today, a dedicated database comprising a standardized questionnaire, as well as multiple data validation processes at different levels in order to assure a better data quality is used.

The aim of the COCONUT II study will collect data of a concomitant PFA based PVI and LAAC approach to treat AF and prevent bleeding and stroke within 12 months. Furthermore, economic factors could be beneficial due to only one concomitant procedure with one hospital stay instead of two procedures with two hospital stays.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Willing to participate
  • Atrial fibrillation and indication for PVI (ESC guideline 2024)
  • Indication for OAC therapy (CHA2DS2VA score >/=2)

Exclusion Criteria:

  • Contraindications for PVI and / or LAA closure
  • Pregnancy
  • Previous catheter ablation for AF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concomitant PVI plus LAAC
Procedure: Interventional LAA Closure
LAA Closure to prevent stroke and bleeding
Procedure: Pulmonary vein isolation
Pulmonary vein isolation for atrial firbrillation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Primary safety endpoint: Major complications, (SAE) within 30 days
Time Frame: 30 days
30 days
• Primary efficacy endpoint: Acute success of PVI and LAA closure
Time Frame: 30 days
30 days
• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios proresearch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COCONUT_2 Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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