Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

NCT ID: NCT01182441

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2017-11-30

Brief Summary

This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.

Conditions

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WATCHMAN

Subjects assigned to receive the WATCHMAN device.

Group Type: EXPERIMENTAL

WATCHMAN Device

Intervention Type: DEVICE

WATCHMAN Left Atrial Appendage Closure Technology

Warfarin

Subjects assigned to warfarin therapy.

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Interventions

WATCHMAN Device

WATCHMAN Left Atrial Appendage Closure Technology

Intervention Type: DEVICE

Warfarin

Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Intervention Type: DRUG

Other Intervention Names

Coumadin

Eligibility Criteria

Inclusion Criteria

• Paroxysmal, persistent or permanent non-valvular AF
• Eligible for long-term warfarin therapy
• Eligible to come off warfarin therapy
• Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:

• Female age 75 or older
• Baseline LVEF ≥ 30 and < 35%
• Aged 65-74 and has diabetes or coronary artery disease
• Aged 65 or greater and has congestive heart failure

Exclusion Criteria

• Contraindicated/allergic to aspirin
• Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
• History of atrial septal repair or has an ASD/PFO device
• Implanted mechanical valve prosthesis
• NYHA Class IV CHF
• Resting heart rate > 110 bpm
• Participated previously in the PROTECT AF or CAP Registry studies

• LVEF < 30%
• Existing pericardial effusion > 2mm
• High risk PFO
• Significant mitral valve stenosis
• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
• Cardiac tumor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R. Holmes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Vivek Y. Reddy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Arizona Heart Rhythm Research Center

Scottsdale, Arizona, United States

Foundation for Cardiovascular Medicine

La Jolla, California, United States

Scripps Green

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Orange County Heart

Orange, California, United States

St. John's Hospital / Pacific Heart

Santa Monica, California, United States

Zasa Clinical Research

Atlantis, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

North Shore University

Evanston, Illinois, United States

Iowa Heart Center

Des Moines, Iowa, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

William Beaumont

Royal Oak, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Cardiology Associates of N. Mississippi

Tupelo, Mississippi, United States

St. Luke's Hospital

Kansas City, Missouri, United States

St. John's Mercy

St Louis, Missouri, United States

Bryan LGH

Lincoln, Nebraska, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

New York University Medical Center

New York, New York, United States

Mt. Sinai School of Medicine

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Moffitt Heart & Vascular

Wormleysburg, Pennsylvania, United States

St. Thomas Research Institute

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia

Austin, Texas, United States

Baylor Research Institute

Dallas, Texas, United States

Methodist Hospital

Houston, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

Fletcher Allen

Burlington, Vermont, United States

Swedish Medical Center

Seattle, Washington, United States

St. Luke's Hospital

Milwaukee, Wisconsin, United States

Countries

United States

References

Dukkipati SR, Holmes DR Jr, Doshi SK, Kar S, Singh SM, Gibson D, Price MJ, Natale A, Mansour M, Sievert H, Houle VM, Allocco DJ, Reddy VY. Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure. J Am Coll Cardiol. 2022 Aug 2;80(5):469-483. doi: 10.1016/j.jacc.2022.04.062.

Reference Type: DERIVED

PMID: 35902169 (View on PubMed)

Friedman DJ, Du C, Wang Y, Agarwal V, Varosy PD, Masoudi FA, Holmes DR, Reddy VY, Price MJ, Curtis JP, Freeman JV. Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials. JACC Cardiovasc Interv. 2022 May 9;15(9):950-961. doi: 10.1016/j.jcin.2022.02.029.

Reference Type: DERIVED

PMID: 35512918 (View on PubMed)

Brouwer TF, Whang W, Kuroki K, Halperin JL, Reddy VY. Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies. J Am Heart Assoc. 2019 Dec 3;8(23):e013525. doi: 10.1161/JAHA.119.013525. Epub 2019 Nov 22.

Reference Type: DERIVED

PMID: 31752643 (View on PubMed)

Price MJ, Reddy VY, Valderrabano M, Halperin JL, Gibson DN, Gordon N, Huber KC, Holmes DR Jr. Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience. JACC Cardiovasc Interv. 2015 Dec 28;8(15):1925-1932. doi: 10.1016/j.jcin.2015.08.035. Epub 2015 Nov 25.

Reference Type: DERIVED

PMID: 26627989 (View on PubMed)

Other Identifiers

CT1004

Identifier Type: -

Identifier Source: org_study_id