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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT03204695

First Posted

June 16, 2017

Last Updated

August 2, 2023

Sponsor

Coherex Medical

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

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

Time Frame

Intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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