WAVECREST Post Market Clinical Follow-Up (PMCF) Study

NCT ID: NCT03204695

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2018-06-14

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

WaveCrest®

Implant of WaveCrest® Left Atrial Appendage Occlusion System

Group Type: EXPERIMENTAL

Percutaneous LAA Closure

Intervention Type: DEVICE

LAA Closure with the WaveCrest LAA Occlusion System (study device)

Anticoagulation or Clopidogrel

Intervention Type: DRUG

Subjects either continue on anticoagulation or receive clopidogrel

Interventions

Percutaneous LAA Closure

LAA Closure with the WaveCrest LAA Occlusion System (study device)

Intervention Type: DEVICE

Anticoagulation or Clopidogrel

Subjects either continue on anticoagulation or receive clopidogrel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Non-valvular paroxysmal, persistent, or permanent atrial fibrillation

2. 18 years of age or older

3. LAA anatomy amenable to treatment by percutaneous techniques

4. Risk factors for potential thrombus formation in the LAA

5. Willing to participate in the required follow-up visits and tests

6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee or Institutional Review Board at the study site

Exclusion Criteria

1. Known contraindication to percutaneous transseptal intervention

2. Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant

3. Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety

4. Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair

5. Known contraindication and/or allergy to nickel

6. Known active bacterial infection (i.e., sepsis, endocarditis)

7. Any known medical condition or overall health of the subject that could adversely affect procedural safety or potentially prevent the patient from completing all study required visits and tests.

8. Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coherex Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom De Potter, MD

Role: PRINCIPAL_INVESTIGATOR

OLV Hospital

Locations

OLV Hospital

Aalst, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CHX_IP015

Identifier Type: -

Identifier Source: org_study_id