Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology

NCT ID: NCT01760291

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2019-04-30

Brief Summary

To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure Technology

Detailed Description

This Continued Access Protocol is a prospective, non-randomized, multicenter study to allow continued access to the WATCHMAN LAA Closure Technology during the data analysis, reporting and review of the PREVAIL pivotal study Pre-Market Application by FDA.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

WATCHMAN

WATCHMAN LAA Closure Technology

Group Type: EXPERIMENTAL

WATCHMAN LAA Closure Technology

Intervention Type: DEVICE

Interventions

WATCHMAN LAA Closure Technology

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject is 18 years of age or older

2. The subject has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)

3. The subject is eligible for long-term warfarin therapy

4. The subject has a calculated CHADS2 score of 2 or greater; Subjects with a CHADS2 score of 1 may be included if any of the following apply (according to the ACC/AHA/ESC 2006 Guidelines for the Management of

Subjects with Atrial Fibrillation subjects requiring warfarin therapy):

• The subject is a female age 75 or older
• The subject has a baseline Left Ventricular Ejection Fraction (LVEF) > 30% and < 35%
• The subject is age 65-74 and has diabetes or coronary artery disease
• The subject is age 65 or greater and has documented congestive heart failure

5. The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial

6. The subject is able and willing to return for required follow-up visits and examinations

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the following criteria:

1. The subject requires long-term warfarin therapy (i.e., even if the device is implanted, the subjects would not be eligible to discontinue warfarin due to other medical conditions requiring chronic warfarin therapy). Additionally, a subject with any of the following is excluded:

• Thrombosis occurring at a young age (<40 years old)
• Idiopathic or recurrent venous thromboembolism
• Thrombosis at an unusual site (i.e., cerebral veins, hepatic veins,renal veins, inferior vena cava, mesenteric veins)
• Family history of venous thromboembolism or of inherited prothrombotic disorder
• Recurrence or extension of thrombosis while adequately anticoagulated

2. The subject is contraindicated for warfarin therapy or cannot tolerate long-term warfarin therapy

3. The subject is contraindicated or allergic to aspirin

4. The subject is indicated for antiplatelet therapy other than aspirin (for example, a subject indicated for clopidogrel, prasugrel, ticlopidine or ticagrelor due to DES is excluded from enrollment during the dosing regimen). A subject completing a course of antiplatelet therapy may be enrolled after a 7 day washout period

5. The subject had any interventional or surgical procedure within 30 days prior to enrollment or is planning to have an interventional or surgical procedure in the time between the WATCHMAN device implant and 45-day TEE (e.g., cardioversion, ablation, cataract surgery, dental surgery)

6. The subject had a prior stroke or TIA within the 90 days prior to enrollment

7. The subject has had an MI within 90 days prior to enrollment

8. The subject has a history of atrial septal repair or has an ASD/PFO device

9. The subject has an implanted mechanical valve prosthesis

10. The subject suffers from New York Heart Association Class IV Congestive Heart Failure at the time of enrollment

11. The subject has symptomatic carotid disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is < 50% stenosis

12. The subject's AF is defined by a single occurrence of AF

13. The subject had a transient case of AF (i.e., secondary to CABG, interventional procedure, etc.)

14. The subject's left atrial appendage is obliterated

15. The subject has undergone heart transplantation

16. The subject is currently treated with antibiotics for an active infection

17. The subject has a resting heart rate > 110 bpm

18. The subject has thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e., anemia as determined by the investigator which would require transfusion)

19. The subject is actively enrolled in a concurrent clinical study of an investigational drug or investigational device (study specifics may be reviewed with the sponsor prior to enrollment to confirm a concurrent study will not interfere with the outcomes of this study)

20. The subject participated in any of the following studies: PROTECT AF, CAP Registry, or PREVAIL. If the subject received a subject ID number for a prior WATCHMAN study, the subject may not be enrolled. PROTECT AF control subjects may be considered for participation if they have completed 5 year follow up

21. The subject is pregnant or pregnancy is planned during the course of the investigation

22. The subject has a life expectancy of less than two years

23. The subject is unable to complete follow-up visits for the duration of the study

1. The subject has LVEF < 30%

2. The subject has intracardiac thrombus or dense spontaneous echo contrast as visualized by TEE and determined by the echocardiographer within 2 days prior to implant

3. The subject has an existing pericardial effusion > 2mm

4. The subject has a high risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm

5. The subject has a high risk PFO with a large shunt defined as early, within 3 beats or substantial passage of bubbles

6. The subject has significant mitral valve stenosis (i.e., MV <1.5 cm2)

7. The subject has complex atheroma with mobile plaque of the descending aorta or aortic arch

8. The subject has a cardiac tumor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saibal Kar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Shephal Doshi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pacific Heart

Locations

Arizona Heart Rhythm Research Center

Phoenix, Arizona, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

References

Dukkipati SR, Holmes DR Jr, Doshi SK, Kar S, Singh SM, Gibson D, Price MJ, Natale A, Mansour M, Sievert H, Houle VM, Allocco DJ, Reddy VY. Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure. J Am Coll Cardiol. 2022 Aug 2;80(5):469-483. doi: 10.1016/j.jacc.2022.04.062.

Reference Type: DERIVED

PMID: 35902169 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

S2278

Identifier Type: -

Identifier Source: org_study_id