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

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT01760291

Run by

Boston Scientific Corporation

People needed

576

Starts

2012-09-01

Expected to finish

2019-04-01

Last updated by the study team

2022-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects will be excluded from the study if they meet any of the following criteria:
• 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
• The subject is contraindicated for warfarin therapy or cannot tolerate long-term warfarin therapy
• The subject is contraindicated or allergic to aspirin
• 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
• 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)
• The subject had a prior stroke or TIA within the 90 days prior to enrollment
• The subject has had an MI within 90 days prior to enrollment
• The subject has a history of atrial septal repair or has an ASD/PFO device
• The subject has an implanted mechanical valve prosthesis
• The subject suffers from New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
• 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
• The subject's AF is defined by a single occurrence of AF
• The subject had a transient case of AF (i.e., secondary to CABG, interventional procedure, etc.)
• The subject's left atrial appendage is obliterated
• The subject has undergone heart transplantation
• The subject is currently treated with antibiotics for an active infection
• The subject has a resting heart rate > 110 bpm
• 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)
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.