NCT03204695

WAVECREST Post Market Clinical Follow-Up (PMCF) Study

A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest® Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Coherex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.

Detailed description

The Coherex WaveCrest® Left Atrial Appendage Occlusion System is designed to permanently occlude the Left Atrial Appendage (LAA).

Conditions

• Non-valvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Percutaneous LAA Closure	LAA Closure with the WaveCrest LAA Occlusion System (study device)
DRUG	Anticoagulation or Clopidogrel	Subjects either continue on anticoagulation or receive clopidogrel

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-06-14
• Completion: 2018-06-14
• First posted: 2017-07-02
• Last updated: 2024-04-23
• Results posted: 2024-04-23

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study