Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology

NCT01760291 | Completed Results DMC

• 1 other identifier: S2278
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 3

Brief Summary

To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure Technology

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Ischemic Stroke

  Primary Endpoint Events by Type for Enrolled Subjects

  5 Year Follow Up

Study Arms (1)

WATCHMAN

EXPERIMENTAL

WATCHMAN LAA Closure Technology

Device: WATCHMAN LAA Closure Technology

Interventions

WATCHMAN LAA Closure Technology DEVICE

WATCHMAN

Eligibility Criteria

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

You may qualify if:

• The subject is 18 years of age or older
• The subject has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)
• The subject is eligible for long-term warfarin therapy
• The subject has a calculated CHADS2 score of 2 or greater; Subjects with a CHADS2 score of 1 may be included if any of the following apply (according to the ACC/AHA/ESC 2006 Guidelines for the Management of
• Subjects with Atrial Fibrillation subjects requiring warfarin therapy):
• The subject is a female age 75 or older
• The subject has a baseline Left Ventricular Ejection Fraction (LVEF) \> 30% and \< 35%
• The subject is age 65-74 and has diabetes or coronary artery disease
• The subject is age 65 or greater and has documented congestive heart failure
• The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
• The subject is able and willing to return for required follow-up visits and examinations

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the following criteria:
• The subject requires long-term warfarin therapy (i.e., even if the device is implanted, the subjects would not be eligible to discontinue warfarin due to other medical conditions requiring chronic warfarin therapy). Additionally, a subject with any of the following is excluded:
• Thrombosis occurring at a young age (\<40 years old)
• Idiopathic or recurrent venous thromboembolism
• Thrombosis at an unusual site (i.e., cerebral veins, hepatic veins,renal veins, inferior vena cava, mesenteric veins)
• Family history of venous thromboembolism or of inherited prothrombotic disorder
• Recurrence or extension of thrombosis while adequately anticoagulated
• The subject is contraindicated for warfarin therapy or cannot tolerate long-term warfarin therapy
• The subject is contraindicated or allergic to aspirin
• The subject is indicated for antiplatelet therapy other than aspirin (for example, a subject indicated for clopidogrel, prasugrel, ticlopidine or ticagrelor due to DES is excluded from enrollment during the dosing regimen). A subject completing a course of antiplatelet therapy may be enrolled after a 7 day washout period
• The subject had any interventional or surgical procedure within 30 days prior to enrollment or is planning to have an interventional or surgical procedure in the time between the WATCHMAN device implant and 45-day TEE (e.g., cardioversion, ablation, cataract surgery, dental surgery)
• The subject had a prior stroke or TIA within the 90 days prior to enrollment
• The subject has had an MI within 90 days prior to enrollment
• The subject has a history of atrial septal repair or has an ASD/PFO device
• The subject has an implanted mechanical valve prosthesis

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Arizona Heart Rhythm Research Center

Phoenix, Arizona, 85006, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 35902169 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Boston Scientific

peter.maurer@bsci.com

18002273422

Study Officials

• Saibal Kar, M.D.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Shephal Doshi, M.D.

  Pacific Heart

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 6, 2012
• First Posted: January 4, 2013
• Study Start: September 1, 2012
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 29, 2022
• Results First Posted: November 24, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)