NCT06007872

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
20mo left

Started Dec 2022

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Dec 2022Dec 2027

Study Start

First participant enrolled

December 2, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 21, 2025

Status Verified

September 1, 2025

Enrollment Period

5.1 years

First QC Date

August 17, 2023

Last Update Submit

October 17, 2025

Conditions

Atrial FibrillationLeft Atrial Appendage Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Successful Watchman implantation using intracardiac echocardiography (ICE) guidance

    Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)

    During the procedure

Study Arms (1)

Intervention

EXPERIMENTAL

Intracardiac Echocardiography (ICE)

Device: Intracardiac Echocardiography (ICE)

Interventions

Intracardiac Echocardiography (ICE)DEVICE

ICE will be used to guide trans-septal puncture and to guide device implant.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
  • Patients receiving a concomitant ablation procedure
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Oussama Wazni, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oussama Wazni, MD

CONTACT

216-444-2131waznio@ccf.org

Study Design

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

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

December 2, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

October 21, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)