Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Closure

(ICETEE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Must not be taking: Oral anticoagulants

Disqualifiers: Intracardiac thrombus, Severe dysfunction, others

Compensation: Varies

Number of Visits: 2

444 Participants Needed

Trial Summary

What is the purpose of this trial?

This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on oral anticoagulants or unable to tolerate them.

What data supports the effectiveness of the treatment Intracardiac Echocardiography for Left Atrial Appendage Closure?

Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage closure, and studies suggest it can effectively guide the procedure with good outcomes, similar to the traditional transesophageal echocardiography (TEE). A meta-analysis found that ICE is a viable alternative to TEE, impacting procedural characteristics and acute outcomes positively. ^{1 2 3 4 5}

Is intracardiac echocardiography generally safe for humans?

The research articles provided do not contain specific safety information about intracardiac echocardiography or transesophageal echocardiography for left atrial appendage closure. ^{6 7 8 9 10}

How does intracardiac echocardiography differ from other treatments for left atrial appendage closure?

Intracardiac echocardiography (ICE) is unique because it allows for left atrial appendage closure without the need for general anesthesia, unlike transesophageal echocardiography (TEE). This makes the procedure potentially safer and more convenient for patients. ^{3 4 11 12 13}

Eligibility Criteria

This trial is for individuals who require a procedure called Left Atrial Appendage Closure (LAAC) to prevent strokes in patients with heart rhythm problems. Participants should be suitable candidates for the closure and able to undergo echocardiography, which is an imaging test of the heart.

Inclusion Criteria

Provide written informed consent before study participation

Patient should be able to comply with the protocol

Patients with increased risk of stroke with elevated CHA2DS2-VASc score

Exclusion Criteria

History of previously implanted device for atrial septal defect or patent foramen ovale

Enrollment in another study that competes or interferes with this study

Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Intracardiac or Transesophageal echocardiography is performed to guide left atrial appendage closure

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

45 days

1 visit (in-person)

Treatment Details

Interventions

• Intracardiac Echocardiography

Trial Overview The study compares two ways of guiding LAAC: using Intracardiac Echocardiography (ICE), a new method where the imaging probe goes inside the heart, versus Transesophageal Echocardiography (TEE), where it's placed in the esophagus behind the heart.

Participant Groups

Group I: Intracardiac echocardiography Left atrial appendage closure. Active Control 1 Intervention

Intra cardiac echocardiography will be performed prior to left atrial appendage closure.

Group II: Traditional transesophageal echocardiography guided Left atrial appendage closure Placebo Group 1 Intervention

Transesophageal Echocardiography will be performed under general anesthesia.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Findings from Research

In a study of 10,885 cardiac catheterizations for congenital heart disease, operators with less than 5 years of experience had significantly higher rates of adverse events (AEs), including preventable AEs, compared to those with 5 to less than 25 years of experience.

Operators with less than 5 years in practice were also more likely to cause vascular or cardiac trauma and technical AEs, highlighting the importance of experience in reducing procedural risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between procedural adverse events associated with cardiac catheterization for congenital heart disease and operator factors: results of a multi-institutional registry (C3PO). Holzer, RJ., Gauvreau, K., Kreutzer, J., et al.[2013]

The review highlights an increasing trend in adverse events associated with clinical catheters, emphasizing the need for better understanding and management of these risks.

By analyzing numerous clinical studies and literature, the review aims to identify common adverse events and their causes, providing evidence to help reduce the incidence of these events and prevent serious complications during catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. Yin, J., Wang, Y., Zhang, L., et al.[2018]

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]

References

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

Role of live/real time three-dimensional transesophageal echocardiography in the percutaneous epicardial closure of the left atrial appendage. [2016]

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

Success of surgical left atrial appendage closure: assessment by transesophageal echocardiography. [2022]

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

Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study. [2023]

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

Impact of intracardiac echocardiography versus transesophageal echocardiography guidance on left atrial appendage occlusion procedures: A meta-analysis. [2023]

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

Left Atrial Appendage Closure Guided by Integrated Echocardiography and Fluoroscopy Imaging Reduces Radiation Exposure. [2018]

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

Relationship between procedural adverse events associated with cardiac catheterization for congenital heart disease and operator factors: results of a multi-institutional registry (C3PO). [2013]

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

Adverse event rates in congenital cardiac catheterization: a new understanding of risks. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A single-center retrospective study with 1-year follow-up after CEA in patients with severe carotid stenosis with contralateral carotid artery occlusion. [2022]

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

Adverse events rates and risk factors in adults undergoing cardiac catheterization at pediatric hospitals--results from the C3PO. [2022]

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

"ICE or not to ICE during LAAO?" What are the benefits and disadvantages of ICE during LAAO? [2019]

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

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

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

Intracardiac echocardiographic imaging with a cartosound module for guidance of left atrial appendage closure: a comparative study with transesophageal echocardiographic imaging. [2023]