Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device

NCT05136417 | Completed Results FDA Device

• 1 other identifier: 21-009613
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.

Conditions

Left Atrial Appendage Occlusion

Outcome Measures

Primary Outcomes (2)

• Successful Implantation of WATCHMAN FLX Device

  Number of participants with a successfully implanted WATCHMAN FLX 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 transesophageal echocardiogram (TEE) 45 days post-implant.

  45 days post procedure

• Major Complications

  Number of participants who experience major complications defined as major bleeding (intracranial bleeding, or bleeding requiring blood transfusion), pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death).

  up to 7 days post procedure

Secondary Outcomes (2)

• Procedure Conversion to General Anesthesia

  baseline

• Iatrogenic Atrial Septal Defect

  45 days post procedure

Study Arms (1)

left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE)

EXPERIMENTAL

100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation.

Device: intra-procedural intracardiac echocardiography (ICE) probe

Interventions

intra-procedural intracardiac echocardiography (ICE) probe DEVICE

placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.

left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 transesophageal echocardiogram (TEE).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Pacific Heart Institute

Santa Monica, California, 98404, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Results Point of Contact

• Title: Dr. Mohamad Alkhouli
• Organization: Mayo Clinic

Alkhouli.Mohamad@mayo.edu

507-255-2502

Study Officials

• Mohamad Adnan Alkhouli, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: November 29, 2021
• Study Start: January 4, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Locations

US (2)