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WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm — WATCH-Rhythm  

Persistent Atrial Fibrillation Clinical Trial

Official title:
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm

Clinical Trial Summary

WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and closure within a single procedure.

Clinical Trial Description

WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and occlusion within a single procedure. The primary objective is to test the effectiveness of adding LAA electrical isolation and closure to conventional atrial fibrillation versus conventional atrial fibrillation alone in treating patient with persistent atrial fibrillation from a single procedure. This study will be conducted at up to 10 global sites in the European Union (United Kingdom, Spain, Germany, or others). The maximum enrollment ceiling for the Watch-Rhythm study is 278 subjects. Included in the enrollment ceiling are up to 20 roll-in subjects and a maximum of 258 randomized subjects. The duration of the study is expected to last approximately 4 years. Enrollment is expected to take approximately 24 months. The duration of individual subject participation is expected to last approximately 2 years but may vary per subject. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03835338
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Withdrawn
Phase N/A
Start date September 1, 2021
Completion date April 30, 2024
View Details
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