The ICE WATCHMAN Trial

NCT ID: NCT04569734

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2023-12-15

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental: Treatment Group

Determination for participation in the study is based on institutional standard of care practice for assessment of WATCHMAN eligibility. Patients that are being considered for LAA Closure with WATCHMAN device implant based on a history of non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2VASc score \>2 but have an appropriate rationale to seek a non-pharmacologic alternative to anti-thrombotic therapy due to risks of anti-thrombotic therapy. Patients should be able to tolerate the WATCHMAN device implant procedure without the need for general anesthesia.

WATCHMAN device implant procedure utilizing ICE probe

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

WATCHMAN

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mohamad Adnan Alkhouli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamad Adnan Alkhouli, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Pacific Heart Institute

Santa Monica, California, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-012524

Identifier Type: -

Identifier Source: org_study_id