NCT03835338

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulmonary Vein Isolation	Pulmonary Vein Isolation by RF Ablation
DEVICE	LAA Isolation	LAA Isolation by RF Ablation
DEVICE	LAA Occlusion	LAA Occlusion by implantation of the WATCHMAN LAAC Device

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-04-30
• Completion: 2024-04-30
• First posted: 2019-02-08
• Last updated: 2022-03-31

Regulatory

• FDA-regulated device study