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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the procedure

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the procedure

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Successful Watchman implantation using intracardiac echocardiography (ICE) guidance

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Intracardiac Echocardiography (ICE)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,365,458 Total Patients Enrolled

Shady Nakhla, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this research being conducted with participant involvement?

"Affirmative. The clinical trial registry states this research is currently recruiting volunteers, starting from December 2nd 2022 and last revised on August 29th 2023. One hundred individuals are needed at a single medical centre."

Answered by AI

Are there any openings remaining for individuals to participate in this investigation?

"Right, according to the information on clinicaltrials.gov this experiment is actively seeking out participants. The original posting was made December 2nd 2022 and it was last modified August 29th 2023. This trial necessitates 100 subjects from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intracardiac Echocardiography Guided Watchman Device Implant

Shady Nakhla, MD 2022. "Intracardiac Echocardiography Guided Watchman Device Implant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007872.