Atrial Fibrillation
Conditions
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.
Interventions
DEVICEWATCHMAN LAA Closure Technology
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A subject may be enrolled in the study if all of the following inclusion criteria are met: 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 Echo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ischemic Stroke | 5 Year Follow Up | Primary Endpoint Events by Type for Enrolled Subjects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WATCHMAN WATCHMAN LAA Closure Technology
WATCHMAN LAA Closure Technology | 576 |
| Total | 576 |
Baseline characteristics
| Characteristic | WATCHMAN |
|---|---|
| Age, Continuous | 75.3 years STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 542 Participants |
| Region of Enrollment United States | 576 participants |
| Sex: Female, Male Female | 227 Participants |
| Sex: Female, Male Male | 349 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 144 / 576 |
| other Total, other adverse events | 16 / 576 |
| serious Total, serious adverse events | 84 / 576 |
Outcome results
Primary
Number of Participants With Ischemic Stroke
Primary Endpoint Events by Type for Enrolled Subjects
Time frame: 5 Year Follow Up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| WATCHMAN | Number of Participants With Ischemic Stroke | 47 Participants |