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

NCT03835338 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Persistent Atrial Fibrillation

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-04-30
Completion
2024-04-30
FDA Device
Yes

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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 NCT03835338 on ClinicalTrials.gov