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Procedure

4D-ICE + TEE Imaging for Atrial Fibrillation

N/A
Recruiting
Led By Dhanunjaya Lakkireddy, MD
Research Sponsored by Kansas City Heart Rhythm Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age:18-80 years
Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days, 6 months and 12 months
Awards & highlights

Study Summary

This trial studies if a new imaging tool can provide better visualization of the heart's anatomy and help guide procedures to close off the left atrium. 52 people will be followed for 12 months.

Who is the study for?
This trial is for men and women aged 18-80 with a history of atrial fibrillation or flutter who are scheduled for a procedure to close off a part of the heart called the left atrial appendage using specific devices. It's not for those with blood clots in that area, pregnant individuals, patients with complex heart anatomy, or those unwilling to consent.Check my eligibility
What is being tested?
The study tests if 4D Intracardiac echocardiography (a type of advanced heart imaging) can provide as clear images as Transesophageal echocardiography during left atrial appendage closure procedures. About 52 participants will be observed over one year without being randomly assigned to groups.See study design
What are the potential side effects?
While this trial focuses on imaging techniques rather than medications, potential side effects may include discomfort from the imaging equipment and risks associated with standard procedural complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I will undergo a procedure to close off a part of my heart using a specific device.
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I have a history of Atrial Fibrillation or Atrial flutter.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days, 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 days, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Success of Implantation of Left Atrial Appendage Closure (LAAC) device
Secondary outcome measures
Intraprocedural measurements
Intraprocedural measurements - LAA device size
Location of the leaks
Other outcome measures
Post Procedural Outcomes
Post Procedural Outcomes - Size of the leaks

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 - ICE Primary Imaging GuidanceExperimental Treatment1 Intervention
4D ICE is the primary imaging guidance and TEE is the secondary
Group II: Arm 1 - TEE Primary imaging guidanceExperimental Treatment1 Intervention
TEE is the primary imaging guidance with 4D ICE is the secondary

Find a Location

Who is running the clinical trial?

Kansas City Heart Rhythm Research FoundationLead Sponsor
26 Previous Clinical Trials
11,920 Total Patients Enrolled
3 Trials studying Stroke
646 Patients Enrolled for Stroke
Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Heart Rhythm Institute
28 Previous Clinical Trials
8,172 Total Patients Enrolled
4 Trials studying Stroke
3,224 Patients Enrolled for Stroke

Frequently Asked Questions

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

Does this medical experiment admit individuals aged 40 and older?

"Adhering to the prerequisite for admission into this trial, participants must be aged 18 or over and below 80."

Answered by AI

Is it possible to become a participant in this experiment?

"To be considered for this clinical trial, participants must have been diagnosed with atrial fibrillation and reside between 18 to 80 years of age. A total of 52 patients are being recruited."

Answered by AI

Are researchers still accepting participants for this research project?

"Affirmative. The details on the clinicaltrials.gov website demonstrate that this investigation is actively in search of participants, having been initially advertised on May 10th 2023 and last updated September 25th 2023. 52 volunteers are being sought at a single medical facility."

Answered by AI

How many individuals are currently being monitored within the scope of this experiment?

"Affirmative. Clinicaltrials.gov hosts data that shows this scientific research, which was initially published on May 10th 2023, is actively recruiting participants. Approximately 52 individuals need to be enrolled from 1 medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Kansas City Heart Rhythm Institute - Roe Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
2023. "Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06061757.
~22 spots leftby Dec 2024
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