Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

NCT ID: NCT02702271

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2021-03-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

WATCHMAN FLX - M

WATCHMAN FLX Main Cohort

Group Type: EXPERIMENTAL

WATCHMAN FLX

Intervention Type: DEVICE

Left atrial appendage closure with WATCHMAN FLX

WATCHMAN FLX - R

WATCHMAN FLX Roll-In Cohort

Group Type: EXPERIMENTAL

WATCHMAN FLX

Intervention Type: DEVICE

Left atrial appendage closure with WATCHMAN FLX

Interventions

WATCHMAN FLX

Left atrial appendage closure with WATCHMAN FLX

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject is 18 years of age or older.

2. 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).

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

4. 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).

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

6. The subject is able to understand and willing to provide written informed consent to participate in the trial.

7. The subject is able and willing to return for required follow-up visits and examinations.

Exclusion Criteria

1. 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.

2. 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).

3. The subject is contraindicated for short-term anticoagulant therapy with DOAC post-implant.

4. The subject is contraindicated to aspirin and/or clopidogrel.

5. The subject is indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to the WATCHMAN FLX Device implant.

6. 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.).

7. 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.

8. 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.

9. The subject has a history of atrial septal repair or has an ASD/PFO device.

10. The subject has an implanted mechanical valve prosthesis in any position.

11. The subject currently has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.

12. 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).

13. The subject has a documented life expectancy of less than 2 years.

• 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

Shephal Doshi, MD

Role: PRINCIPAL_INVESTIGATOR

St. John's Health Center

Saibal Kar, MD

Role: PRINCIPAL_INVESTIGATOR

Los Robles Regional Medical Center

Locations

Grandview Medical Center

Birmingham, Alabama, United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Nair Research, LLC

Jonesboro, Arkansas, United States

Scripps Green

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Sharpe Chula Vista Medical Center

San Diego, California, United States

St. John's Hospital / Pacific Heart

Santa Monica, California, United States

Washington Hospital Center

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

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, United States

Cardiology Associates of N. Mississippi

Tupelo, Mississippi, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Cardiovascular Associates of the Delaware Valley

Sewell, 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

Cleveland Clinic

Cleveland, Ohio, United States

Legacy Emanuel Hospital & Health Center

Portland, Oregon, United States

York Hospital

York, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia

Austin, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

PeaceHealth Southwest Medical

Vancouver, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33820423 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

91081206

Identifier Type: -

Identifier Source: org_study_id