Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: WATCHMAN FLX

• Registration Number: NCT02702271
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-08
• Study Start: 2018-05-07
• Primary Completion: 2020-01-28
• Study Completion: 2021-03-12
• Results First Submitted: 2021-10-27
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Results First Posted: 2022-06-14
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
WATCHMAN FLX - R	WATCHMAN FLX	WATCHMAN FLX Roll-In Cohort
WATCHMAN FLX - M	WATCHMAN FLX	WATCHMAN FLX Main Cohort

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Safety Event	events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later	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.
Number of Participants With Effective LAA Closure	12-months	The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months.

Trial Locations

Locations (29)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Tallahassee Memorial Hospital; 🇺🇸 Tallahassee, Florida, United States

St. John's Hospital / Pacific Heart; 🇺🇸 Santa Monica, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

York Hospital; 🇺🇸 York, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Sharpe Chula Vista Medical Center; 🇺🇸 San Diego, California, United States

Phoenix Cardiovascular Research Group; 🇺🇸 Phoenix, Arizona, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

St. Joseph's Hospital & Medical Center; 🇺🇸 Phoenix, Arizona, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Grandview Medical Center; 🇺🇸 Birmingham, Alabama, United States

Nair Research, LLC; 🇺🇸 Jonesboro, Arkansas, United States

Scripps Green; 🇺🇸 La Jolla, California, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

HealthEast St. Joseph's Hospital; 🇺🇸 Saint Paul, Minnesota, United States

Catholic Medical Center; 🇺🇸 Manchester, New Hampshire, United States

Cardiology Associates of N. Mississippi; 🇺🇸 Tupelo, Mississippi, United States

New York University Medical Center; 🇺🇸 New York, New York, United States

St. Luke's Hospital; 🇺🇸 Kansas City, Missouri, United States

Cardiovascular Associates of the Delaware Valley; 🇺🇸 Sewell, New Jersey, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Mt. Sinai School of Medicine; 🇺🇸 New York, New York, United States

Legacy Emanuel Hospital & Health Center; 🇺🇸 Portland, Oregon, 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