The ICE WATCHMAN Trial

Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study (Data Coordinating Center)

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.

Study Overview

• Status: Completed
• Conditions: Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe
• Intervention / Treatment: Procedure: WATCHMAN device implant procedure utilizing ICE probe

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.

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 98404
      • Pacific Heart Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: WATCHMAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mohamad Adnan Alkhouli, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-012524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes