Clinical trial NCT03204695: WAVECREST Post Market Clinical Follow-Up (PMCF) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-valvular Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation
Atrial Fibrillation
Stroke
Left Atrial Appendage (LAA)
LAA Closure
LAA Occlusion
WaveCrest
Lead sponsor: Coherex Medical
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

Eligibility 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.

Primary outcomes:
measure: Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)
timeFrame: From baseline up to 45 days
Secondary outcomes:
measure: Percentage of Participants Who Achieved Device Success
timeFrame: From baseline up to 45 days
measure: Percentage of Participants Who Achieved Technical Success
timeFrame: From baseline up to 45 days
measure: Percentage of Participants Who Achieved Procedural Success
timeFrame: From baseline up to 45 days
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
Study officials:
affiliation: OLV Hospital
name: Tom De Potter, MD
role: PRINCIPAL_INVESTIGATOR
References: