Concomitant PFA Bsaed PVI Plus LAAC

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Bleeding Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interventional LAA Closure

Procedure

LAA Closure to prevent stroke and bleeding

pulmonary vein isolation

Procedure

Pulmonary vein isolation for atrial firbrillation treatment

Primary outcomes

• Primary safety endpoint: Major complications, (SAE) within 30 days

Time frame: 30 days
• Primary efficacy endpoint: Acute success of PVI and LAA closure

Time frame: 30 days
• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days

Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Christian-Hendrik Heeger, MD

CONTACT

[email protected]

0049-40-181881-8904

Sponsors and collaborators

Lead sponsor

Asklepios proresearch

Industry

Registry information

Official study title

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

Acronym: COCONUT_2

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Mar 5, 2026
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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