Using advanced imaging techniques for heart procedure guidance
Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)
This study is testing if a new imaging technique called 4D Intracardiac Echocardiography can help doctors perform heart procedures more safely and comfortably for patients compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kansas City Heart Rhythm Research Foundation Academic / other |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT06061757 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 4D Intracardiac Echocardiography (4D-ICE) in providing better visualization and guidance during Left Atrial Appendage Closure (LAAC) procedures compared to the traditional Transesophageal Echocardiography (TEE). It is a prospective, single-center, non-randomized study with two parallel arms, enrolling approximately 52 subjects who will be followed for 12 months. The goal is to determine if 4D-ICE can improve procedural outcomes while allowing the use of local anesthesia instead of general anesthesia, potentially reducing complications and discomfort for patients. The study aims to assess the safety and feasibility of this new imaging technique in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-80 with a history of atrial fibrillation or flutter who require endocardial LAAC.
Not a fit: Patients with complex anatomy for LAAC, thrombus in the left atrial appendage, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more comfortable LAAC procedures for patients with atrial fibrillation.
How similar studies have performed: Previous studies have shown that intracardiac echocardiography can be a safe and feasible alternative to TEE, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male/Females * Age:18-80 years * History of Atrial Fibrillation/Atrial flutter * Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device Exclusion Criteria: * Inability or unwillingness of an individual to give written informed consent * Patient not following with our practice after the procedure * Complex anatomy for endocardial LAAC * Thrombus in LAA * Patients with pericardial effusion in pre-op TEE/CCTA * Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)
Where this trial is running
Overland Park, Kansas
- Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Dhanunjaya Lakkireddy, MD — Kansas City Heart Rhythm Institute
- Study coordinator: Donita Atkins
- Email: datkins@kchrf.com
- Phone: 816-651-1969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.