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Procedure

ICE-Guided Watchman Device Implantation for Atrial Fibrillation

N/A
Recruiting
Led By Shady Nakhla, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients receiving a concomitant ablation procedure
Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effectiveness of Intracardiac Echocardiography (ICE) when placing the Watchman device in patients, compared to current Transesophageal Echocardiography (TEE).

Who is the study for?
This trial is for patients who qualify for a Watchman heart device implant and aren't part of another clinical study. It's not for those getting an ablation procedure, with prior incomplete left atrial appendage closure, or issues that complicate trans-septal equipment delivery like PFO or ASD closures.
What is being tested?
The study tests the effectiveness of using Intracardiac Echocardiography (ICE) instead of Transesophageal Echocardiography (TEE) to place the Watchman device in patients with conditions like Atrial Fibrillation.
What are the potential side effects?
While specific side effects are not listed, procedures involving ICE may include risks such as bleeding at the catheter site, infection, and potential complications related to heart interventions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am undergoing a procedure to destroy abnormal tissue.
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I had an incomplete procedure to close off a part of my heart.
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I need a heart device implant but cannot undergo a certain heart scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Successful Watchman implantation using intracardiac echocardiography (ICE) guidance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Intracardiac Echocardiography (ICE)

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,660 Total Patients Enrolled
22 Trials studying Atrial Fibrillation
5,467 Patients Enrolled for Atrial Fibrillation
Shady Nakhla, MDPrincipal InvestigatorThe Cleveland Clinic
~33 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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