4D-ICE + TEE Imaging for Atrial Fibrillation

Overseen By Donita Atkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kansas City Heart Rhythm Research Foundation

Disqualifiers: Complex anatomy, Thrombus in LAA, Pericardial effusion, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to guide a procedure called Left Atrial Appendage Closure (LAAC), which helps prevent strokes in individuals with atrial fibrillation, a heart rhythm disorder. The trial compares two imaging techniques: 4D Intracardiac Echocardiography (4D-ICE) and Transesophageal Echocardiography (TEE), to determine which provides better guidance during the procedure. Participants may qualify if they have experienced atrial fibrillation and plan to undergo LAAC using an Amplatzer Amulet or WATCHMAN FLX device. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future stroke prevention methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging technique is safe for atrial fibrillation procedures?

Previous studies found 4D Intracardiac Echocardiography (ICE) to be safe. Various heart procedures used it, and patients handled it well, with no major issues reported.

In contrast, Transesophageal Echocardiography (TEE) has a mixed safety record. Although usually safe, serious problems have occurred in about 5.3% to 6.1% of cases during heart procedures.

Both 4D ICE and TEE have specific safety considerations. While 4D ICE seems to cause fewer problems, TEE remains widely used and trusted, despite some risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 4D-ICE + TEE imaging techniques for atrial fibrillation because these methods could enhance the precision and safety of left atrial appendage closure. Traditional approaches often rely on transesophageal echocardiography (TEE) alone for imaging, but this trial explores using 4D intracardiac echocardiography (ICE) as a primary or secondary imaging method. The use of 4D ICE offers a non-invasive and potentially more detailed visualization of the heart's structures, which could improve procedural outcomes and reduce the risk of complications. By evaluating these imaging techniques, researchers hope to discover more effective ways to guide heart procedures, ultimately leading to better patient care.

What evidence suggests that this trial's imaging techniques could be effective for atrial fibrillation?

This trial compares two imaging guidance methods for heart procedures related to atrial fibrillation. Research has shown that 4D Intracardiac Echocardiography (ICE), used as the primary imaging guidance in Arm 2, effectively guides heart procedures. It provides live images of the heart, aiding doctors in performing procedures safely. Early clinical experience demonstrated that 4D ICE is both safe and helpful for these interventions.

Participants in Arm 1 will receive Transesophageal Echocardiography (TEE) as the primary imaging guidance. TEE has a long history of success and effectively prevents strokes in patients with certain heart conditions, such as atrial fibrillation. Although more invasive than ICE, TEE remains a trusted and reliable method for heart imaging and guiding procedures. Both imaging techniques are valuable for guiding heart procedures and ensuring successful outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am either male or female.

I will undergo a procedure to close off a part of my heart using a specific device.

I have a history of Atrial Fibrillation or Atrial flutter.

Exclusion Criteria

Your heart has a complicated structure for a specific kind of procedure.

You have fluid around your heart before the operation.

I will not continue care with the practice after my procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraprocedural Guidance

Participants undergo left atrial appendage closure (LAAC) with either TEE or 4D ICE as primary imaging guidance

1 day

1 visit (in-person)

Post Procedural Follow-up

Participants are monitored for post-procedural outcomes such as leaks, device-related thrombus, and procedural success

12 months

3 visits (in-person) at 45 days, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Imaging guidance with TEE and ICE
• Left atrial appendage closure

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 2 - ICE Primary Imaging Guidance Experimental Treatment 1 Intervention

4D ICE is the primary imaging guidance and TEE is the secondary

Group II: Arm 1 - TEE Primary imaging guidance Experimental Treatment 1 Intervention

TEE is the primary imaging guidance with 4D ICE is the secondary

Left atrial appendage closure is already approved in European Union, United States for the following indications:

Approved in European Union as LAAO for:

• Prevention of cardio-embolic stroke in patients with atrial fibrillation at high bleeding risk

Approved in United States as LAAO for:

• Prevention of cardio-embolic stroke in patients with atrial fibrillation at high bleeding risk

Who Is Running the Clinical Trial?

Kansas City Heart Rhythm Research Foundation

Lead Sponsor

Trials

30

Recruited

14,000+

Published Research Related to This Trial

In a pilot study involving 24 patients, 3D-CT guided left atrial appendage occlusion (LAAO) demonstrated a significantly higher accuracy in device selection (92%) compared to transesophageal echocardiography (TEE) (27%), leading to improved procedural outcomes.

The use of 3D-CT also resulted in greater procedural efficiency, with shorter procedure times (55 minutes for 3D-CT vs. 73 minutes for TEE) and fewer devices and guide catheters used, indicating that 3D-CT can simplify the LAAO process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, randomized comparison of 3-dimensional computed tomography guidance versus TEE data for left atrial appendage occlusion (PRO3DLAAO). Eng, MH., Wang, DD., Greenbaum, AB., et al.[2019]

Left atrial appendage occlusion (LAAO) is a promising technology that relies on advanced imaging techniques, such as 2D and 3D transesophageal echocardiography combined with fluoroscopy, to guide the procedure effectively.

Successful LAAO requires careful attention to transseptal puncture, appropriate device size selection, and thorough post-deployment evaluation to check for leaks and complications, highlighting the importance of precise anatomical understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Echocardiographic Imaging for Left Atrial Appendage Occlusion: Transesophageal Echocardiography and Intracardiac Echocardiographic Imaging. Wang, DD., Forbes, TJ., Lee, JC., et al.[2019]

In a study involving 15 patients with atrial fibrillation, real-time three-dimensional volume intracardiac echocardiography (4D volume ICE) provided comparable measurements to transesophageal echocardiography (TEE) for guiding left atrial appendage closure, indicating its potential as an alternative imaging method.

While 4D volume ICE showed good correlation with TEE measurements, the imaging success rate was lower (67% for ICE vs. 100% for TEE), suggesting that patient selection and preprocedural planning are crucial for optimizing ICE guidance in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

4D Volume Intracardiac Echocardiography for Intraprocedural Guidance of Transcatheter Left Atrial Appendage Closure. Khalili, H., Patton, M., Taii, HA., et al.[2022]

Intracardiac echocardiography (ICE) from the left atrium is as effective as transesophageal echocardiography (TEE) for guiding transcatheter left atrial appendage occlusion (LAAO), achieving a technical success rate of 99% in both methods.

ICE demonstrated a lower rate of major periprocedural complications (1.8%) compared to TEE (4.7%), and also reduced turnover time and contrast use in the catheter laboratory, suggesting it may be a safer and more efficient alternative to TEE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. Korsholm, K., Jensen, JM., Nielsen-Kudsk, JE.[2019]

In a study of 126 patients with atrial fibrillation, left atrial appendage closure (LAAC) using non-fluoroscopic guidance with transesophageal echocardiography (TEE) was found to be as effective as fluoroscopic guidance, with a 100% success rate in occluding the left atrial appendage for both methods.

The complication rates were comparable between the TEE group and the fluoroscopic group, suggesting that non-fluoroscopic LAAC is a safe alternative for high-risk patients who may not tolerate contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of a percutaneous and non-fluoroscopic procedure for left atrial appendage closure in patients for whom fluoroscopy presents risk: a cohort study. Zou, M., Zhuang, D., Sievert, H., et al.[2023]

In a study of 286 patients undergoing left atrial appendage occlusion (LAAO), both intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) demonstrated similar technical success rates (97.8% for ICE vs. 97.4% for TEE) and comparable rates of major procedure-related events (3.3% for ICE vs. 4.1% for TEE).

ICE-guided LAAO resulted in shorter in-room times compared to TEE (78.7 minutes vs. 113.6 minutes), but overall hospital charges were similar between the two methods, indicating that ICE can be a safe and efficient alternative to TEE for guiding LAAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Routine Intracardiac Echocardiography to Guide Left Atrial Appendage Occlusion. Alkhouli, M., Chaker, Z., Alqahtani, F., et al.[2021]

Using intracardiac echocardiography (ICE) for left atrial appendage closure (LAAC) with the Watchman device is safe and effective, achieving a 100% implant success rate without complications, similar to traditional transesophageal echocardiography (TEE).

ICE significantly reduces procedural times and avoids the need for general anesthesia, leading to lower professional fees while maintaining comparable overall costs to TEE, making it a more efficient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations. Hemam, ME., Kuroki, K., Schurmann, PA., et al.[2020]

Transcatheter left atrial appendage occlusion (LAAO) is becoming a popular alternative to oral anticoagulation for patients with atrial fibrillation, highlighting its growing importance in managing this condition.

Intracardiac echocardiography (ICE) is proposed as a valuable alternative to the traditional transesophageal echocardiography (TEE) for guiding LAAO, with this paper providing a standardized protocol to enhance its clinical adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document. Berti, S., Pastormerlo, LE., Korsholm, K., et al.[2021]

Left atrial appendage closure (LAAC) is a procedure used for patients with nonvalvular atrial fibrillation who cannot take long-term anticoagulants, and it is becoming more common.

The article discusses the shift from traditional transesophageal echocardiography (TEE) to intracardiac echocardiography (ICE) for guiding LAAC, highlighting the benefits and techniques of using ICE in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Intracardiac Echography for Transcatheter Occlusion of Left Atrial Appendage. Patel, A., Valderrábano, M.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38789491/

Real-world experience utilizing the nuvision 4D ... There was no significant difference in device implant success or post procedural outcomes at 45 days in either the TEE or 4D ICE group. However, ...

2. ahajournals.org ahajournals.org/doi/pdf/10.1161/JAHA.124.037019

Dimensional Intracardiac Echocardiography Catheter to ... The primary efficacy end point included technical success, imaging success, and clinical success. RESULTS: Between October 2021 and November 2022, 155 patients ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jce.16309

Step‐by‐step recommendations utilizing four‐dimensional ... Initial clinical experience using the 4D ICE catheter demonstrated its safety and utility as an intracardiac and intraluminal guidance catheter ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843406/

Clinical Outcomes of Intracardiac Echocardiography ... ICE‐guided radiofrequency catheter ablation is safe and effective in the treatment of AF, and it has potential advantages in terms of ablation time, radiation ...

5. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(22)01222-X/fulltext

PO-696-06 REAL-WORLD EXPERIENCE WITH A NOVEL ... Intracardiac echocardiography (ICE) is a valuable imaging modality which allows real-time visualization of cardiac anatomy for procedural guidance.

6. withpower.com withpower.com/trial/phase-atrial-fibrillation-4-2023-9ff89

4D-ICE + TEE Imaging for Atrial Fibrillation Is 4D-ICE + TEE Imaging for Atrial Fibrillation safe for humans? Research shows that using intracardiac echocardiography (ICE) and transesophageal ...

7. ctv.veeva.com ctv.veeva.com/study/use-of-4d-ice-in-conjunction-with-tee-for-left-atrial-appendage-closure

Use of 4D-ICE in Conjunction With TEE for Left Atrial ... This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography ...