52 Participants Needed

4D-ICE + TEE Imaging for Atrial Fibrillation

DA
Overseen ByDonita Atkins
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kansas City Heart Rhythm Research Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12678

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.12789

Who Is on the Research Team?

Dhanunjaya DJ Lakkireddy MD, Clinical ...

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.
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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?
2Treatment groups
Experimental Treatment
Group I: Arm 2 - ICE Primary Imaging GuidanceExperimental Treatment1 Intervention
Group II: Arm 1 - TEE Primary imaging guidanceExperimental Treatment1 Intervention

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

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as LAAO for:
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as LAAO for:

Find a Clinic Near You

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

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.
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.
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.
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]

Citations

Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations. [2020]
Intracardiac echocardiography for guidance of transcatheter left atrial appendage occlusion: An expert consensus document. [2021]
Prospective, randomized comparison of 3-dimensional computed tomography guidance versus TEE data for left atrial appendage occlusion (PRO3DLAAO). [2019]
Role of Intracardiac Echography for Transcatheter Occlusion of Left Atrial Appendage. [2021]
Echocardiographic Imaging for Left Atrial Appendage Occlusion: Transesophageal Echocardiography and Intracardiac Echocardiographic Imaging. [2019]
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]
Outcomes of Routine Intracardiac Echocardiography to Guide Left Atrial Appendage Occlusion. [2021]
Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. [2019]
4D Volume Intracardiac Echocardiography for Intraprocedural Guidance of Transcatheter Left Atrial Appendage Closure. [2022]
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