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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02702271
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : June 14, 2022
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: WATCHMAN FLX Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : January 28, 2020
Actual Study Completion Date : March 12, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With a Safety Event [ Time Frame: 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.

  2. Number of Participants With Effective LAA Closure [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702271


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Shephal Doshi, MD St. John's Health Center
Principal Investigator: Saibal Kar, MD Los Robles Regional Medical Center
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Study Protocol and Statistical Analysis Plan  [PDF] April 12, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02702271    
Other Study ID Numbers: 91081206
First Posted: March 8, 2016    Key Record Dates
Results First Posted: June 14, 2022
Last Update Posted: June 14, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes