Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe
Conditions
Brief summary
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.
Detailed description
The study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation. The primary feasibility endpoint will be ability to 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. The primary safety endpoint will be a composite of major complications (major bleeding \[intracranial bleeding, or bleeding requiring blood transfusion\], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death). Additional measured end points will be: freedom from conversion to general anesthesia and/or standard TEE during implant, the incidence and the size of iatrogenic atrial septal defect on 45 day TEE. The ICE procedural images will also be collected and analyzed by an independent committee composed of non-implanting interventionalist, and an imaging specialist. The images will be graded in quality as optimal (TEE equivalent), acceptable (adequate but not as detailed as TEE), and inadequate. This prospective study, along with its endpoints will be registered in clinicaltrials.gov.
Interventions
PROCEDUREWATCHMAN device implant procedure utilizing ICE probe
The study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successfully implant the WATCHMAN device | 45 days post-implant | 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 |
| Absence of a composite of major complications | 7 days post-implant | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from conversion to general anesthesia and/or standard TEE during implant | During procedure | Freedom from conversion to general anesthesia and/or standard TEE during implant |
| Freedom from the incidence and the size of iatrogenic atrial septal defect | 45 days post-implant | Freedom from the incidence and the size of iatrogenic atrial septal defect on 45 day TEE |
Countries
United States
Outcome results
None listed