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Completed

NCT Number: NCT05136417

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

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.

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Key information

Conditions

Left Atrial Appendage Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pacific Heart Institute, Santa Monica, California, United States

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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 transesophageal echocardiogram (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

intra-procedural intracardiac echocardiography (ICE) probe

Device

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

Primary outcomes

  1. Successful Implantation of WATCHMAN FLX Device

    Time frame: 45 days post procedure

    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.

  2. Major Complications

    Time frame: up to 7 days post procedure

    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).

Secondary outcomes

  1. Procedure Conversion to General Anesthesia

    Time frame: baseline

    Number of participants who required conversion from moderate sedation to general anesthesia for implant procedure.

  2. Iatrogenic Atrial Septal Defect

    Time frame: 45 days post procedure

    Number of participants with an iatrogenic atrial septal defect.

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 29, 2021
Registry last updated
Dec 27, 2024

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.

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