Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

Status: Completed
Location: See all (29) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• The subject is 18 years of age or older.

• The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).

• The subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN FLX Device implant.

• The subject is eligible to come off of anticoagulation therapy if the LAA is sealed (i.e., the subject has no other conditions that would require long-term anticoagulation therapy suggested by current standard medical practice).

• The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.

• The subject 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.

Locations
United States
Alabama
Grandview Medical Center
Birmingham
Arkansas
Nair Research, LLC
Jonesboro
Arizona
Phoenix Cardiovascular Research Group
Phoenix
St. Joseph's Hospital & Medical Center
Phoenix
California
Scripps Green
La Jolla
Cedars-Sinai Medical Center
Los Angeles
Sharpe Chula Vista Medical Center
San Diego
St. John's Hospital / Pacific Heart
Santa Monica
Washington, D.c.
Washington Hospital Center
Washington
Florida
Tallahassee Memorial Hospital
Tallahassee
Georgia
Emory University
Atlanta
Massachusetts
Massachusetts General Hospital
Boston
Michigan
Henry Ford Hospital
Detroit
Minnesota
Mayo Clinic
Rochester
HealthEast St. Joseph's Hospital
Saint Paul
Missouri
St. Luke's Hospital
Kansas City
Mississippi
Cardiology Associates of N. Mississippi
Tupelo
New Hampshire
Catholic Medical Center
Manchester
New Jersey
Cardiovascular Associates of the Delaware Valley
Sewell
New York
Mt. Sinai School of Medicine
New York
New York University Medical Center
New York
Ohio
Cleveland Clinic
Cleveland
Oregon
Legacy Emanuel Hospital & Health Center
Portland
Pennsylvania
York Hospital
York
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Texas Cardiac Arrhythmia
Austin
Virginia
Sentara Norfolk General Hospital
Norfolk
Virginia Commonwealth University Health System
Richmond
Washington
PeaceHealth Southwest Medical
Vancouver
Time Frame
Start Date: May 7, 2018
Completion Date: March 12, 2021
Participants
Target number of participants: 458
Treatments
Experimental: WATCHMAN FLX - M
WATCHMAN FLX Main Cohort
Experimental: WATCHMAN FLX - R
WATCHMAN FLX Roll-In Cohort
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

Similar Clinical Trials