The ICE WATCHMAN Trial

• ClinicalTrials.gov Identifier: NCT04569734
• Recruitment Status: Enrolling by invitation
• First Posted: September 30, 2020
• Last Update Posted: November 7, 2022
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Mohamad Adnan Alkhouli, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment
Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe	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 Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study (Data Coordinating Center)
• Actual Study Start Date: September 22, 2020
• Estimated Primary Completion Date: September 2023
• Estimated Study Completion Date: September 2023

Groups and Cohorts

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 Name: WATCHMAN

Outcome Measures

Primary Outcome Measures :

1. Successfully implant the WATCHMAN device [ Time Frame: 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
2. Absence of a composite of major complications [ Time Frame: 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)
3. Absence of a composite of major complications [ Time Frame: 45 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 Outcome Measures :

1. Freedom from conversion to general anesthesia and/or standard TEE during implant [ Time Frame: During procedure ]
   Freedom from conversion to general anesthesia and/or standard TEE during implant
2. Freedom from the incidence and the size of iatrogenic atrial septal defect [ Time Frame: 45 days post-implant ]
   Freedom from the incidence and the size of iatrogenic atrial septal defect on 45 day TEE

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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.

Contacts and Locations

Locations

United States, California

Pacific Heart Institute

Santa Monica, California, United States, 98404

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Mohamad Adnan Alkhouli, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Mohamad Adnan Alkhouli, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04569734
• Other Study ID Numbers: 19-012524
• First Posted: September 30, 2020
• Last Update Posted: November 7, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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