Clinical trial NCT01182441: Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Official title: Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Stroke
Keywords: atrial fibrillation
stroke
TIA
trans ischemic attack
warfarin
Coumadin
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-08-16
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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

Key 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

Key Echo Exclusion Criteria:

* 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

Primary outcomes:
measure: Primary Safety Endpoint (Device Group Only)
timeFrame: 7-Day
measure: Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)
timeFrame: 18 month rate
measure: Composite of Ischemic Stroke or Systemic Embolism
timeFrame: Day 8 to 18-months
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Heart Rhythm Research Center
state: Arizona
city: La Jolla
country: United States
facility: Foundation for Cardiovascular Medicine
state: California
city: La Jolla
country: United States
facility: Scripps Green
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: Orange County Heart
state: California
city: Santa Monica
country: United States
facility: St. John's Hospital / Pacific Heart
state: California
city: Atlantis
country: United States
facility: Zasa Clinical Research
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Evanston
country: United States
facility: North Shore University
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates of N. Mississippi
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. John's Mercy
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Moffitt Heart & Vascular
state: Pennsylvania
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen
state: Vermont
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Hospital
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: David R. Holmes, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Y. Reddy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.