MedTrace Logo

WAVECREST Post Market Clinical Follow-Up (PMCF) Study

NCT03204695 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-04-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Non-valvular Atrial Fibrillation

Interventions

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

Sponsors & Collaborators

  • Coherex Medical

    lead INDUSTRY

Principal Investigators

  • Tom De Potter, MD · OLV Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-29
Primary Completion
2018-06-14
Completion
2018-06-14
FDA Device
Yes

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT03204695 on ClinicalTrials.gov