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WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

NCT03302494 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2025-03-12

Study results available
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Summary

The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

Conditions

Interventions

DEVICE

Coherex WaveCrest® Left Atrial Appendage Occlusion System

Percutaneous left atrial appendage closure

DEVICE

Watchman® LAA Closure Device

Percutaeous left atrial appendage closure

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Coherex Medical

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · MOUNT SINAI HOSPITAL

  • Gregg Stone, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2023-12-21
Completion
2023-12-21
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

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 NCT03302494 on ClinicalTrials.gov