Clinical trial NCT02702271: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Official title: Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A total of 400 main cohort subjects and 58 roll-in subjects were enrolled at 29 investigational centers in the United States.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Participants With a Safety Event
timeFrame: events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later
measure: Number of Participants With Effective LAA Closure
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Jonesboro
country: United States
facility: Nair Research, LLC
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Green
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Sharpe Chula Vista Medical Center
state: California
city: Santa Monica
country: United States
facility: St. John's Hospital / Pacific Heart
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates of N. Mississippi
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Sewell
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Legacy Emanuel Hospital & Health Center
state: Oregon
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
Study officials:
affiliation: St. John's Health Center
name: Shephal Doshi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Los Robles Regional Medical Center
name: Saibal Kar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.