Completed

NCT Number: NCT04569734

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 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pacific Heart Institute, Santa Monica, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WATCHMAN device implant procedure utilizing ICE probe

Procedure

Other names: WATCHMAN

Primary outcomes

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
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)
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 outcomes

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
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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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)

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Sep 30, 2020
Registry last updated: Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.