RECRUITING

Intracardiac Echocardiography Guided Watchman Device Implant

Conditions

Atrial Fibrillation Left Atrial Appendage Thrombosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.

Official Title

Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant

Quick Facts

Study Start:2022-12-02

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06007872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial	* Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed. * Patients receiving a concomitant ablation procedure * Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures * Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).

Inclusion Criteria

Exclusion Criteria

* All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial

* Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
* Patients receiving a concomitant ablation procedure
* Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
* Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).

Contacts and Locations

Study Contact

Shady Nakhla, MD

CONTACT

216-445-9474

NAKHLAS@ccf.org

Principal Investigator

Shady Nakhla, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Shady Nakhla, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-02

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-12-02

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Atrial Fibrillation
Left Atrial Appendage Thrombosis