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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03302494




Registration number
NCT03302494
Ethics application status
Date submitted
29/09/2017
Date registered
5/10/2017

Titles & IDs
Public title
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
Scientific 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.
Secondary ID [1] 0 0
CHX_IP014
Universal Trial Number (UTN)
Trial acronym
WAVECREST2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Coherex WaveCrest® Left Atrial Appendage Occlusion System
Treatment: Devices - Watchman® LAA Closure Device

Experimental: WaveCrest - WaveCrest left atrial appendage occluder

Active comparator: Watchman (control) - Watchman left atrial appendage closure device


Treatment: Devices: Coherex WaveCrest® Left Atrial Appendage Occlusion System
Percutaneous left atrial appendage closure

Treatment: Devices: Watchman® LAA Closure Device
Percutaeous left atrial appendage closure
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedure or device related complications
Timepoint [1] 0 0
45 Days
Primary outcome [2] 0 0
All Death
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Major Bleeding
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
Ischemic stroke, systemic embolism
Timepoint [4] 0 0
24 months
Secondary outcome [1] 0 0
Ischemic stroke, systemic embolism
Timepoint [1] 0 0
45 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2023
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Melbourne
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
2023 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Coherex Medical
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Biosense Webster, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vivek Reddy, MD
Address 0 0
MOUNT SINAI HOSPITAL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03302494