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WATCH - TAVR study (WATCHMAN FOR PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT)
To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR)
Primary Outcome Measures:
Compostie of all-cause mortality, stroke and bleeding ( Time Frames: 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.
Secondary Outcome Measures:
1. All-cause mortality (Time Frame: Through 1 year post-randomization) All deaths through 1 year.
2. Stroke (Time Frame: Through 1 year post-randomization) First occurrence of any ischemic or hemorrhagic stroke through 1 year.
3. Bleeding ( Time Frame: Through 1 year post-randomization) First occurrence of any life-threatening or major bleeding through 1 year.
Other Outcome Measures:
1. Cardiovascular mortality ( Time Frame: Through 1 year post-randomization) Cardiovascular related mortality through 1 year
2. Thrombus or embolism ( Time Frame: Through 1 year post-randomization) Incidence or arterial or venous embolism
3. Re-hospitalization (Time Frame: Through 1 year post-randomization) Incidence of re-hospitalizations related to the WATCHMAN procedure or device
4. Quality of Life ( Time Frame: Through 1 year post-randomization) Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score
5. Procedural costs (Time Frame: from initial hospitalization to discharge) Procedural costs realed to the initial TAVR and WATCHMAN procedures
To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR)
Primary Outcome Measures:
Compostie of all-cause mortality, stroke and bleeding ( Time Frames: 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.
Secondary Outcome Measures:
1. All-cause mortality (Time Frame: Through 1 year post-randomization) All deaths through 1 year.
2. Stroke (Time Frame: Through 1 year post-randomization) First occurrence of any ischemic or hemorrhagic stroke through 1 year.
3. Bleeding ( Time Frame: Through 1 year post-randomization) First occurrence of any life-threatening or major bleeding through 1 year.
Other Outcome Measures:
1. Cardiovascular mortality ( Time Frame: Through 1 year post-randomization) Cardiovascular related mortality through 1 year
2. Thrombus or embolism ( Time Frame: Through 1 year post-randomization) Incidence or arterial or venous embolism
3. Re-hospitalization (Time Frame: Through 1 year post-randomization) Incidence of re-hospitalizations related to the WATCHMAN procedure or device
4. Quality of Life ( Time Frame: Through 1 year post-randomization) Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score
5. Procedural costs (Time Frame: from initial hospitalization to discharge) Procedural costs realed to the initial TAVR and WATCHMAN procedures
Recruitment Status
Past Studies