WAVECREST Post Market Clinical Follow-Up (PMCF) Study

Non-valvular Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03204695
• Other study ID #: CHX_IP015
• Status: Terminated
• Phase: N/A
• Start date: May 29, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: March 2024
• Source: Coherex Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst

Sponsors (1)

Lead Sponsor	Collaborator
Coherex Medical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With All-cause Mortality, Pericardial Effusion Requiring Intervention, Device Embolization (Major), Device Thrombus and Ischemic Stroke (Composite Primary Safety Endpoint)	The primary safety outcome was the composite of death from any cause (all-cause mortality), pericardial effusion requiring intervention, device embolization (major), device thrombus and ischemic stroke up to 45 days. The analysis was based on Sponsor Assessment of Adverse Events data. Baseline was defined as the last available measurement on or before the date of the implantation procedure.	From baseline up to 45 days
Secondary	Percentage of Participants Who Achieved Device Success	Percentage of participants who achieved device success were reported. Device success was defined as the percentage of participants who had the device deployed and implanted in the correct position. Baseline was defined as the last available measurement on or before the date of the implantation procedure.	From baseline up to 45 days
Secondary	Percentage of Participants Who Achieved Technical Success	Percentage of participants who achieved technical success were reported. Technical success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak greater than [>]5 millimeters [mm] on color Doppler transesophageal echocardiogram [TEE]) and who were discharged from the cardiac catheterization laboratory without the occurrence of device-related complications. Baseline was defined as the last available measurement on or before the date of the implantation procedure.	From baseline up to 45 days
Secondary	Percentage of Participants Who Achieved Procedural Success	Percentage of participants who achieved procedural success were reported. Procedural success was defined as the percentage of participants who experienced successful placement and release of the occluder in the LAA with LAA closure (defined as no leak >5 mm on color Doppler TEE) and who were discharged from the cardiac catheterization laboratory without device-related complications and without procedure-related complications other than minor device embolization (defined as device embolization that can be resolved by percutaneous technique without surgical intervention or damage to surrounding cardiovascular structures). Baseline was defined as the last available measurement on or before the date of the implantation procedure.	From baseline up to 45 days