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The ICE WATCHMAN Trial

NCT04569734 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2023-12-27

No results posted yet for this 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.

Conditions

  • Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe

Interventions

PROCEDURE

WATCHMAN 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 & Collaborators

Principal Investigators

  • Mohamad Adnan Alkhouli, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2023-12-15
Completion
2023-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04569734 on ClinicalTrials.gov