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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 : Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE March 3, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE May 7, 2018
Actual Primary Completion Date January 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • Procedure-related complications [ Time Frame: 7 days or Discharge; 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.
  • Device Closure [ Time Frame: 12-months ]
    The rate of effective LAA closure defined as any peri-device flow < 5mm demonstrated by TEE at 12 months
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
procedural complications [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
Ischemic stroke, systemic embolism [ Time Frame: 24-months ]
The occurrence of ischemic stroke or systemic embolism
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Official Title  ICMJE Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: WATCHMAN FLX
Left atrial appendage closure with WATCHMAN FLX
Study Arms  ICMJE Experimental: WATCHMAN FLX
WATCHMAN FLX implant: This is a single arm study
Intervention: Device: WATCHMAN FLX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
458
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE February 2021
Actual Primary Completion Date January 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02702271
Other Study ID Numbers  ICMJE 91081206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shephal Doshi, MD St. John's Health Center
Principal Investigator: Saibal Kar, MD Los Robles Regional Medical Center
PRS Account Boston Scientific Corporation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP