Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology

Atrial Fibrillation Clinical Trial

— PINNACLE FLX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702271
• Other study ID #: 91081206
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: March 12, 2021

Study information

• Verified date: May 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: March 12, 2021
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• WATCHMAN FLX
Left atrial appendage closure with WATCHMAN FLX

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Grandview Medical Center	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Nair Research, LLC	Jonesboro	Arkansas
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Scripps Green	La Jolla	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mt. Sinai School of Medicine	New York	New York
United States	New York University Medical Center	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Legacy Emanuel Hospital & Health Center	Portland	Oregon
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Sharpe Chula Vista Medical Center	San Diego	California
United States	St. John's Hospital / Pacific Heart	Santa Monica	California
United States	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Cardiology Associates of N. Mississippi	Tupelo	Mississippi
United States	PeaceHealth Southwest Medical	Vancouver	Washington
United States	Washington Hospital Center	Washington	District of Columbia
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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