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NCT04569734 · ClinicalTrials.gov registry record
The ICE WATCHMAN Trial
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 101
- Enrollment target
NCT04569734: Completed study, sponsored by Mayo Clinic.
NCT04569734 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 101 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04569734 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 101 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE WATCHMAN device implant procedure utilizing ICE probe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2023-12-15 |
What the finished NCT04569734 record still lists
NCT04569734 is an observational study that tracks outcomes without assigning an intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which WATCHMAN device implant procedure utilizing ICE probe is the first listed.
NCT04569734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04569734 about?
NCT04569734 is a clinical study titled "The ICE WATCHMAN Trial". 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 ne...
What is the current status of trial NCT04569734?
This trial is currently completed. The enrollment target is 101 participants. The study started on 2020-09-22. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT04569734?
The interventions under investigation include: WATCHMAN device implant procedure utilizing ICE probe (PROCEDURE).
Who is sponsoring clinical trial NCT04569734?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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