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Concomitant PFA Bsaed PVI Plus LAAC

NCT07450755 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Interventional LAA Closure

LAA Closure to prevent stroke and bleeding

PROCEDURE

Pulmonary vein isolation

Pulmonary vein isolation for atrial firbrillation treatment

Sponsors & Collaborators

  • Asklepios proresearch

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2027-12-31

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Entities

Diseases

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 NCT07450755 on ClinicalTrials.gov