WAVECREST Post Market Clinical Follow-Up (PMCF) Study
Primary Purpose
Non-valvular Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Percutaneous LAA Closure
Anticoagulation or Clopidogrel
Sponsored by
About this trial
This is an interventional prevention trial for Non-valvular Atrial Fibrillation focused on measuring Non-valvular atrial fibrillation, Atrial Fibrillation, Stroke, Left Atrial Appendage (LAA), LAA Closure, LAA Occlusion, WaveCrest
Eligibility Criteria
The criteria for implant are in accordance to the current version of the Instructions for Use:
Inclusion Criteria:
- Non-valvular paroxysmal, persistent, or permanent atrial fibrillation
- 18 years of age or older
- LAA anatomy amenable to treatment by percutaneous techniques
- Risk factors for potential thrombus formation in the LAA
- Willing to participate in the required follow-up visits and tests
- 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:
- Known contraindication to percutaneous transseptal intervention
- Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant
- Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety
- Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair
- Known contraindication and/or allergy to nickel
- Known active bacterial infection (i.e., sepsis, endocarditis)
- 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.
- Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.
Sites / Locations
- OLV Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WaveCrest®
Arm Description
Implant of WaveCrest® Left Atrial Appendage Occlusion System
Outcomes
Primary Outcome Measures
Incidence of all-cause deaths and device and/or procedure related events while using the WaveCrest device
Composite rate consists of:
All-cause mortality
Pericardial effusion requiring intervention
Device embolization from the Left Atrial Appendage (LAA)
Device thrombus
Ischemic stroke
Secondary Outcome Measures
Rate of successful device release within LAA
Position confirmed by imaging
Technical Success at implant
Occlusion of the LAA
No device-related complications
No leak >5mm on color Doppler Transesophageal Echocardiography (TEE)
Procedural Success
Technical success
No procedure-related complications except uncomplicated (minor) device embolization (resolved by percutaneous retrieval during the procedure without surgical intervention or damage to surrounding cardiovascular structures)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03204695
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Study closed due to device design modifications.
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coherex Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-valvular Atrial Fibrillation
Keywords
Non-valvular atrial fibrillation, Atrial Fibrillation, Stroke, Left Atrial Appendage (LAA), LAA Closure, LAA Occlusion, WaveCrest
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WaveCrest®
Arm Type
Experimental
Arm Description
Implant of WaveCrest® Left Atrial Appendage Occlusion System
Intervention Type
Device
Intervention Name(s)
Percutaneous LAA Closure
Intervention Description
LAA Closure with the WaveCrest LAA Occlusion System (study device)
Intervention Type
Drug
Intervention Name(s)
Anticoagulation or Clopidogrel
Intervention Description
Subjects either continue on anticoagulation or receive clopidogrel
Primary Outcome Measure Information:
Title
Incidence of all-cause deaths and device and/or procedure related events while using the WaveCrest device
Description
Composite rate consists of:
All-cause mortality
Pericardial effusion requiring intervention
Device embolization from the Left Atrial Appendage (LAA)
Device thrombus
Ischemic stroke
Time Frame
45 Days
Secondary Outcome Measure Information:
Title
Rate of successful device release within LAA
Description
Position confirmed by imaging
Time Frame
Intraoperative
Title
Technical Success at implant
Description
Occlusion of the LAA
No device-related complications
No leak >5mm on color Doppler Transesophageal Echocardiography (TEE)
Time Frame
Intraoperative
Title
Procedural Success
Description
Technical success
No procedure-related complications except uncomplicated (minor) device embolization (resolved by percutaneous retrieval during the procedure without surgical intervention or damage to surrounding cardiovascular structures)
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The criteria for implant are in accordance to the current version of the Instructions for Use:
Inclusion Criteria:
Non-valvular paroxysmal, persistent, or permanent atrial fibrillation
18 years of age or older
LAA anatomy amenable to treatment by percutaneous techniques
Risk factors for potential thrombus formation in the LAA
Willing to participate in the required follow-up visits and tests
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:
Known contraindication to percutaneous transseptal intervention
Left atrial appendage anatomy or size that will not allow appropriate implantation of the WaveCrest Implant
Intracardiac thrombus or other cardiac abnormality visualized prior to implant that would significantly impact procedural safety
Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular disease or history of mitral valve replacement or repair
Known contraindication and/or allergy to nickel
Known active bacterial infection (i.e., sepsis, endocarditis)
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.
Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications associated with the implant procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom De Potter, MD
Organizational Affiliation
OLV Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV Hospital
City
Aalst
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Site-specific clinical study results may be published by Investigators in compliance with the Investigator Agreement and/or site agreement, as applicable.
Learn more about this trial
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
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