WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
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|ClinicalTrials.gov Identifier: NCT03173534|
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Aortic Valve Stenosis||Device: WATCHMAN Device: TAVR||Not Applicable|
WATCH-TAVR is a prospective, multicenter, randomized controlled trial. Only centers with approval for commercial WATCHMAN implantation will be included in this trial. Subjects will be enrolled at up to 25 centers in the United States. There will be up to 312 subjects enrolled, with 156 patients randomized to TAVR + medical therapy and 156 patients randomized to simultaneous TAVR+WATCHMAN to accumulate the necessary 191 primary events. Enrollment is expected to occur over the course of 18 months. Patients will be followed for a total of 2 years. Patients with non-valvular AF undergoing standard of care commercial TAVR will be enrolled in the trial.
For patients who receive the WATCHMAN device, plan of care will follow WATCHMAN labeling.Patients randomized to receive the WATCHMAN device will receive anticoagulation with warfarin and aspirin for 6 weeks after the procedure. After 6 weeks, the plan of care will follow WATCHMAN labeling. Patients randomized to the TAVR + medical therapy arm will be treated in accordance with standard of care with either warfarin, other anticoagulant/antiplatelet therapy, or no anticoagulation at the discretion of the treating physician. All patients will continue to receive routine post-TAVR follow-up and care.Patients will be monitored for primary and secondary endpoints as outlined. Baseline information and laboratory data will be collected as described in the protocol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized in a 1:1 allocation ratio to the following treatment arms TAVR + Medical Therapy (n=156) or simultaneous TAVR + WATCHMAN (n=156)|
|Masking:||None (Open Label)|
|Official Title:||WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: TAVR + Medical Therapy
n=156 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
Transcatheter Aortic Valve Replacement
Experimental: TAVR + WATCHMAN
n=156 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.
WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.
Transcatheter Aortic Valve Replacement
- Composite of all-cause mortality, stroke and bleeding [ Time Frame: Through 1 year post-randomization ]First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 1 year
- All-cause mortality [ Time Frame: Through 1 year post-randomization ]All deaths through 1 year
- Stroke [ Time Frame: Through 1 year post-randomization ]First occurrence of any ischemic or hemorrhagic stroke through 1 year
- Bleeding [ Time Frame: Through 1 year post-randomization ]First occurrence of any life-threatening or major bleeding through 1 year
- Cardiovascular mortality [ Time Frame: Through 1 year post-randomization ]Cardiovascular related mortality through 1 year
- Thrombus or embolism [ Time Frame: Through 1 year post-randomization ]Incidence of arterial or venous embolism
- Re-hospitalization [ Time Frame: Through 1 year post-randomization ]Incidence of re-hospitalizations related to the WATCHMAN procedure or device
- Quality of Life Score: KCCQ-12 [ Time Frame: Through 1 year post-randomization ]Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool used to assess heart failure and how it affects the participant's life. Four domain scores and one summary score are generated from the KCCQ-12: Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score and a Summary Score. Scale ranges for each question 1 to 6 (Extremely limited 1, Quite a bit limited 2, Moderately limited 3, Slightly limited 4, Not at all limited 5, Limited for other reasons or did not do the activity 6. The Summary score represents an integration of the patient's physical limitation, symptom frequency, quality of life and social limitation. The score is calculated as the average. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest
- Procedural costs [ Time Frame: from initial hospitalization to discharge ]Procedural costs related to the initial TAVR and WATCHMAN procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173534
|Contact: Allison Kirkholder, BSNfirstname.lastname@example.org|
|Contact: Ellen S McErlean, MSNemail@example.com|
|Principal Investigator:||Samir Kapadia, MD||The Cleveland Clinic|