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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
Must not have
Thrombus in LAA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 days, 6 months and 12 months
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I am between 18 and 80 years old.
Select...
I will undergo a procedure to close off a part of my heart using a specific device.
Select...
I have a history of Atrial Fibrillation or Atrial flutter.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a blood clot in my heart's left atrial appendage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45 days, 6 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 days, 6 months and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Success of Implantation of Left Atrial Appendage Closure (LAAC) device
Secondary study objectives
Intraprocedural measurements
Intraprocedural measurements - LAA device size
Location of the leaks
Other study objectives
Post Procedural Outcomes
Post Procedural Outcomes - Size of the leaks
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
28 Previous Clinical Trials
13,846 Total Patients Enrolled
14 Trials studying Atrial Fibrillation
6,082 Patients Enrolled for Atrial Fibrillation
Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Heart Rhythm Institute
29 Previous Clinical Trials
9,608 Total Patients Enrolled
15 Trials studying Atrial Fibrillation
5,260 Patients Enrolled for Atrial Fibrillation