Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe Clinical Trial
Official title:
Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study (Data Coordinating Center)
| Verified date | December 2023 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. By eliminating the need for general anesthesia, the hope is to show a reduction in procedural time, decrease use of supplemental invasive procedures (central venous line, invasive arterial pressure monitoring and transesophageal echocardiography) and quicker patient recovery time. This approach can decrease healthcare resource utilization and safely simplify left atrial appendage closure with the WATCHMAN device.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | December 15, 2023 |
| Est. primary completion date | December 15, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - The patients is eligible to undergo WATCHMAN device implant procedure - The patient is eligible for short term anticoagulation therapy - Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s) - Ability to give informed consent for the procedure - The patient is able and willing to undergo the procedure under moderate sedation - The patient is able and willing to return for required 45-day TEE. Exclusion Criteria: - Patient has contraindication for short term anticoagulation - The patient has history of a hypercoagulable state per medical record documentation - Pregnancy or planning to get pregnant during the investigation. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | Pacific Heart Institute | Santa Monica | California |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successfully implant the WATCHMAN device | Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant | 45 days post-implant | |
| Primary | Absence of a composite of major complications | Absence of a composite of major complications such major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death) | 7 days post-implant | |
| Primary | Absence of a composite of major complications | Absence of a composite of major complications such major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death) | 45 days post-implant | |
| Secondary | Freedom from conversion to general anesthesia and/or standard TEE during implant | Freedom from conversion to general anesthesia and/or standard TEE during implant | During procedure | |
| Secondary | Freedom from the incidence and the size of iatrogenic atrial septal defect | Freedom from the incidence and the size of iatrogenic atrial septal defect on 45 day TEE | 45 days post-implant |