WAVECREST Post Market Clinical Follow-Up (PMCF) Study

NCT03204695 | Terminated Results DMC FDA Device

• 1 other identifier: CHX_IP015
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-valvular Atrial Fibrillation

Keywords

Non-valvular atrial fibrillation; Atrial Fibrillation; Stroke; Left Atrial Appendage (LAA); LAA Closure; LAA Occlusion; WaveCrest

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants Who Achieved Device Success

  From baseline up to 45 days

• Percentage of Participants Who Achieved Technical Success

  From baseline up to 45 days

• Percentage of Participants Who Achieved Procedural Success

  From baseline up to 45 days

Study Arms (1)

WaveCrest®

EXPERIMENTAL

Implant of WaveCrest® Left Atrial Appendage Occlusion System

Device: Percutaneous LAA Closure; Drug: Anticoagulation or Clopidogrel

Interventions

Percutaneous LAA Closure DEVICE

LAA Closure with the WaveCrest LAA Occlusion System (study device)

WaveCrest®

Anticoagulation or Clopidogrel DRUG

Subjects either continue on anticoagulation or receive clopidogrel

WaveCrest®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-valvular paroxysmal, persistent, or permanent atrial fibrillation
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coherex Medical: lead

Study Sites (1)

OLV Hospital

Aalst, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Coherex Medical, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Tom De Potter, MD

  OLV Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: July 2, 2017
• Study Start: May 29, 2017
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2018
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Locations

BE (1)