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

Trial Summary

What is the purpose of this trial?

This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.

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 data supports the effectiveness of the treatment 4D-ICE + TEE Imaging for Atrial Fibrillation?

Research shows that using intracardiac echocardiography (ICE) for left atrial appendage occlusion (LAAO) can simplify the procedure by avoiding general anesthesia and making it less invasive. Additionally, ICE is increasingly used as an alternative to transesophageal echocardiography (TEE) for guiding LAAO, which is a common procedure for patients with atrial fibrillation who cannot take long-term blood thinners. ^{1 2 3 4 5}

Is 4D-ICE + TEE Imaging for Atrial Fibrillation safe for humans?

Research shows that using intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE) for guiding left atrial appendage occlusion (LAAO) is generally safe. ICE can reduce the need for general anesthesia and simplify the procedure, which may enhance safety for patients. ^{1 2 6 7 8}

How is the 4D-ICE + TEE treatment for atrial fibrillation different from other treatments?

The 4D-ICE + TEE treatment for atrial fibrillation is unique because it uses real-time three-dimensional intracardiac echocardiography (ICE) instead of the traditional transesophageal echocardiography (TEE), which can eliminate the need for general anesthesia and simplify the procedure to a simple venous puncture, making it less invasive and potentially more comfortable for patients. ^{1 2 3 4 9}

Research Team

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Eligibility Criteria

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 am between 18 and 80 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Prospective, randomized comparison of 3-dimensional computed tomography guidance versus TEE data for left atrial appendage occlusion (PRO3DLAAO). [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Role of Intracardiac Echography for Transcatheter Occlusion of Left Atrial Appendage. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Echocardiographic Imaging for Left Atrial Appendage Occlusion: Transesophageal Echocardiography and Intracardiac Echocardiographic Imaging. [2019]

6. China 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Routine Intracardiac Echocardiography to Guide Left Atrial Appendage Occlusion. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

4D Volume Intracardiac Echocardiography for Intraprocedural Guidance of Transcatheter Left Atrial Appendage Closure. [2022]