Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

NCT02702271 | Completed Results DMC FDA Device

• 1 other identifier: 91081206
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 29

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Safety Event

  The occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint.

  events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later

• Number of Participants With Effective LAA Closure

  The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months.

  12-months

Study Arms (2)

WATCHMAN FLX - M

EXPERIMENTAL

WATCHMAN FLX Main Cohort

Device: WATCHMAN FLX

WATCHMAN FLX - R

EXPERIMENTAL

WATCHMAN FLX Roll-In Cohort

Device: WATCHMAN FLX

Interventions

WATCHMAN FLX DEVICE

Left atrial appendage closure with WATCHMAN FLX

WATCHMAN FLX - M; WATCHMAN FLX - R

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, 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.

You may not qualify if:

• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
• The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoaguable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue anticoagulation due to other medical conditions requiring chronic anticoagulation therapy).
• The subject is contraindicated for short-term anticoagulant therapy with DOAC post-implant.
• The subject is contraindicated to aspirin and/or clopidogrel.
• The subject is indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to the WATCHMAN FLX Device implant.
• The subject had or is planning to have any cardiac or non-cardiac invasive or surgical procedure within 30 days prior to or 60 days after the WATCHMAN FLX Device implant (including, but not limited to: cardioversion, coronary angiogram with or without percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, endoscopy, etc.).
• The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
• The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, 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 in any position.
• The subject currently has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.
• The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
• The subject has a documented life expectancy of less than 2 years.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (29)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85006, United States

Location

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85016, United States

Location

Nair Research, LLC

Jonesboro, Arkansas, 72401, United States

Location

Scripps Green

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sharpe Chula Vista Medical Center

San Diego, California, 92121, United States

Location

St. John's Hospital / Pacific Heart

Santa Monica, California, 90404, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

Cardiology Associates of N. Mississippi

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Cardiovascular Associates of the Delaware Valley

Sewell, New Jersey, 08080, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97227, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23219, United States

Location

PeaceHealth Southwest Medical

Vancouver, Washington, 98664, United States

Location

Related Publications (1)

• Kar S, Doshi SK, Sadhu A, Horton R, Osorio J, Ellis C, Stone J Jr, Shah M, Dukkipati SR, Adler S, Nair DG, Kim J, Wazni O, Price MJ, Asch FM, Holmes DR Jr, Shipley RD, Gordon NT, Allocco DJ, Reddy VY; PINNACLE FLX Investigators. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021 May 4;143(18):1754-1762. doi: 10.1161/CIRCULATIONAHA.120.050117. Epub 2021 Apr 6.

  PMID: 33820423 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

1-800-CARDIAC

Study Officials

• Shephal Doshi, MD

  St. John's Health Center

  PRINCIPAL INVESTIGATOR

• Saibal Kar, MD

  Los Robles Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 400 main cohort subjects and 58 roll-in subjects were enrolled at 29 investigational centers in the United States.

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: May 7, 2018
• Primary Completion: January 28, 2020
• Study Completion: March 12, 2021
• Last Updated: June 14, 2022
• Results First Posted: June 14, 2022

Record last verified: 2022-05

Locations

US (29)