Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02928497|
Recruitment Status : Active, not recruiting
First Posted : October 10, 2016
Last Update Posted : November 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: WATCHMAN LAAC Device Implant Drug: Single Antiplatelet Therapy or No Therapy (Control)||Not Applicable|
The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke.
Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||481 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)|
|Actual Study Start Date :||February 15, 2017|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: WATCHMAN (Device)
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
Device: WATCHMAN LAAC Device Implant
WATCHMAN LAAC Implant
Active Comparator: Control
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
Drug: Single Antiplatelet Therapy or No Therapy (Control)
Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
- Primary 7-Day Device/Procedural Safety Endpoint [ Time Frame: 7 days ]The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
- Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism. [ Time Frame: 5 years ]The primary efficacy endpoint is the comparison of time to first event of ischemic stroke and systemic embolism.
- Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death [ Time Frame: 5 years ]The occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism
- Secondary Endpoint - Major Bleeding [ Time Frame: 5 years ]The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)
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): NCT02928497
|Principal Investigator:||Jacqueline Saw, MD||Vancouver General Hospital|
|Principal Investigator:||Vivek Reddy, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Maurice Buchbinder, MD||Stanford University|