WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2

Stroke Clinical Trial

— WAVECREST2  

Official title:

WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2. A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the Coherex WaveCrest® Left Atrial Appendage Occlusion System Compared to the Watchman® LAA Closure Device for the Reduction in Risk of Ischemic Stroke or Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation That Have an Appropriate Rationale to Seek a Non-pharmacologic Alternative to Chronic Oral Anticoagulation.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03302494
• Other study ID #: CHX_IP014
• Status: Terminated
• Phase: Phase 3
• Start date: December 27, 2017
• Est. completion date: December 21, 2023

Study information

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

Clinical Trial Summary

The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

Description:

The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System. Subjects will be randomized in a 1:1 ratio to the Treatment Arm (Coherex WaveCrest LAA occlusion system) or the Control Arm (Boston Scientific's Watchman LAA occlusion system). The trial is designed to demonstrate that safety and effectiveness of the WaveCrest device are non-inferior to the Watchman device.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 248
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation

2. At least 18 years of age

3. Calculated CHADS2 score = 2 or CHA2DS2-VASc score = 3

4. Indication for warfarin therapy with an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation

5. Willing and able to comply with post-implant anticoagulation and antiplatelet regimen

6. Willing to participate in the required follow-up visits and tests

7. Subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB/EC at the site

Exclusion Criteria:

1. Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or postoperative)

2. Known contraindication and/or allergy to warfarin, nickel, aspirin, intravenous contrast or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel), which cannot be adequately pre-medicated or desensitized

3. Conditions other than AF requiring long-term anticoagulation therapy

4. Contraindications for percutaneous catheterization procedures

5. Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any prior attempt of such procedures

6. Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal defect

7. Inability or unwillingness to take oral anticoagulation for 45 days post-procedure

8. New York Heart Association (NYHA) Class IV heart failure

9. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant

10. History of symptomatic carotid, intervertebral, or intracranial artery occlusion or stenosis without revascularization with the exception of known occlusion without symptoms > 6 months

11. Modified Rankin Scale (mRS) score = 4

12. Chronic resting heart rate = 110 bpm

13. Congenital cardiac anomalies requiring cardiac surgery or interventional repair

14. Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to enrollment

15. Myocardial infarction within 60 days prior to enrollment

16. Sepsis or any infection requiring oral antibiotic therapy within 14 days or intravenous antibiotic therapy within 30 days prior to enrollment

17. Surgical or interventional cardiovascular and non-cardiovascular procedure including cardioversion within 30 days prior to enrollment or AF ablation within 60 days prior to enrollment or any planned general surgery or interventional procedure within 90 days after enrollment or any planned cardiac surgery.

18. On renal replacement therapy, serum creatinine > 3.0 mg/dl (265 µmol/L) or calculated creatinine clearance < 25 ml/minute

19. Thrombocytopenia (<60,000 platelets/mm3), leucopenia (white blood cell count < 3,000 cells/mm³), or anemia (hemoglobin concentration < 10 grams/deciliter) based on blood work done within 30 days prior to enrollment

20. Any medical disorder or psychiatric illness that would interfere with successful completion of the trial

21. Currently participating in an investigational drug trial or another device trial that has not completed the primary endpoint (trials requiring extended follow-up for products that are commercially available are not considered investigational trials). Concurrent enrollment in the ACC LAAO Registry is permitted.

22. Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and Definitions)

23. Any condition that would reduce life expectancy to less than 2 years

24. Women of childbearing potential who are, or plan to become pregnant during the time of the trial (method of assessment per physician discretion) Echocardiographic Exclusion Criteria

1. Left ventricular ejection fraction < 30%

2. Mitral valve stenosis defined as valve area < 1.5cm2, mean gradient > 6mmHg, or any valve deformity consistent with rheumatic valvular disease

3. Aortic valve stenosis defined as valve area =1.0cm2 or mean gradient >30mmHg

4. Circumferential pericardial effusion > 10mm or symptomatic pericardial effusion

5. Evidence of intracardiac thrombus

6. Cardiac tumor or myxoma

7. Atrial septal defect that warrants closure

8. Complex atheroma in the ascending aorta or aortic arch as evidenced by mobile plaque

9. Left Atrial Appendage size and shape are unsuitable for closure with a WaveCrest or Watchman device

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Coherex WaveCrest® Left Atrial Appendage Occlusion System
Percutaneous left atrial appendage closure
• Watchman® LAA Closure Device
Percutaeous left atrial appendage closure

Locations

Country	Name	City	State
Australia	Monash Health	Melbourne
Australia	St. Vincent's Hospital	Sydney
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Northwell Health	Bay Shore	New York
United States	Grandview Medical Center	Birmingham	Alabama
United States	Dignity Health Mercy Gilbert Medical Center	Chandler	Arizona
United States	Ohio State University	Columbus	Ohio
United States	Baylor Scott & White All Saints Medical Center	Fort Worth	Texas
United States	UPMC Pinnacle Health Cardiovascular Institute	Harrisburg	Pennsylvania
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Pacific Heart Institute / St. John's Health Center	Los Angeles	California
United States	Wellstar Kennestone	Marietta	Georgia
United States	Marquette General Hospital	Marquette	Michigan
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York University	New York	New York
United States	New York University- NYU Langone Cardiac	New York	New York
United States	Heart Hospital Baylor Plano (Baylor Research Institute)	Plano	Texas
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Munson Medical Center	Traverse City	Michigan
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi
United States	Christus Trinity Clinic Research	Tyler	Texas
United States	Medstar Heart and Vascular Institute - Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Coherex Medical	Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure or device related complications	Part of the composite rate of the primary safety endpoint.	45 Days
Primary	All Death	Part of the composite rate of the primary safety endpoint.	24 months
Primary	Major Bleeding	Part of the composite rate of the primary safety endpoint.	24 months
Primary	Ischemic stroke, systemic embolism	The primary effectiveness endpoint is a composite rate of ischemic stroke or systemic embolism at 24 months	24 months
Secondary	Ischemic stroke, systemic embolism	The secondary endpoint is the rate of ischemic stroke or systemic embolism with the WaveCrest device in comparison to the CHADS2 and CHA2DS2-VASc imputed risk of ischemic stroke or systemic embolism in the absence of anticoagulant therapy	45 days