One-Stop shop: new study tests dual procedure for AFib patients

NCT ID NCT07349121

Recruiting now Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 5 times

Summary

This study is testing whether it is safe and effective to perform two heart procedures at the same time in people with atrial fibrillation (AF). The first procedure uses pulsed field ablation to correct the heart's rhythm, and the second closes off a small pouch in the heart to reduce stroke risk. About 500 participants across Europe, the Middle East, and Africa will be followed for 30 days to check for complications and treatment success.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: FARAPULSE Pulsed Field Ablation System and WATCHMAN FLX Pro or WATCHMAN FLX device
What this could lead to: If successful, this could show that combining two procedures in one session is safe and effective for managing atrial fibrillation and reducing stroke risk.
What could go wrong: This is an observational post-market study, not a randomized controlled trial, so results may not prove superiority. Risks include procedure-related serious adverse events like bleeding or device complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ATRIAL FIBRILLATION (AF) ATRIAL FIBRILLATION ABLATION PROCEDURE CONCOMITANT PROCEDURES LEFT ATRIAL APPENDAGE CLOSURE PULSED-FIELD ABLATION STROKE PREVENTION IN PATIENTS WITH ATRIAL FIBRILLATION

Contacts and locations

Locations

AZORG - Hospital
RECRUITING

Aalst, Belgium
Clinique Pasteur - Toulouse
NOT_YET_RECRUITING

Toulouse, France
IRCCS Policlinico San Donato
RECRUITING

San Donato Milanese, Italy
Klinicki bolnicki centar Zagreb
RECRUITING

Zagreb, Croatia
University Hospital of Salamanca
NOT_YET_RECRUITING

Salamanca, Spain

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