Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology (PINNACLE FLX)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: WATCHMAN FLX

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Phoenix Cardiovascular Research Group
    • Phoenix, Arizona, United States, 85016
      • St. Joseph's Hospital & Medical Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Nair Research, LLC
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • San Diego, California, United States, 92121
      • Sharpe Chula Vista Medical Center
    • Santa Monica, California, United States, 90404
      • St. John's Hospital / Pacific Heart
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates of N. Mississippi
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Sewell, New Jersey, United States, 08080
      • Cardiovascular Associates of the Delaware Valley
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center
    • New York, New York, United States, 10029
      • Mt. Sinai School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital & Health Center
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Health System
  • Washington
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WATCHMAN FLX - M; WATCHMAN FLX Main Cohort	Device: WATCHMAN FLX; Left atrial appendage closure with WATCHMAN FLX
Experimental: WATCHMAN FLX - R; WATCHMAN FLX Roll-In Cohort	Device: WATCHMAN FLX; Left atrial appendage closure with WATCHMAN FLX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Shephal Doshi, MD, St. John's Health Center; Principal Investigator: Saibal Kar, MD, Los Robles Regional Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 91081206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No