WAVECREST Post Market Clinical Follow-Up (PMCF) Study

Coherex Medical

Status: Terminated

Conditions: Non-valvular Atrial Fibrillation

Treatments: Drug: Anticoagulation or Clopidogrel; Device: Percutaneous LAA Closure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03204695

CHX_IP015

Details and patient eligibility

About

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.

Full description

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The criteria for implant are in accordance to the current version of the Instructions for Use:

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

WaveCrest®

Experimental group

Description:

Implant of WaveCrest® Left Atrial Appendage Occlusion System

Treatment:

Device: Percutaneous LAA Closure

Drug: Anticoagulation or Clopidogrel