Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Closure

(ICETEE Trial)

Overseen By Bonnie Ostergren

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods used during a procedure to prevent strokes in individuals with atrial fibrillation. One group will undergo a procedure using intracardiac echocardiography (ICE), which functions like an ultrasound from inside the heart. The other group will use the traditional method with transesophageal echocardiography (TEE), an ultrasound taken by passing a probe down the esophagus. The researchers aim to determine if ICE is a safe and practical alternative to TEE. Individuals with atrial fibrillation who are at high risk of stroke and seek alternatives to long-term blood-thinning medication might be suitable for this study. As an unphased trial, this study offers patients the chance to explore innovative methods that could enhance their treatment options.

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 prior data suggests that these echocardiography techniques are safe for left atrial appendage closure?

Research has shown that using intracardiac echocardiography (ICE) for closing the left atrial appendage is generally safe. One study reported a 97.2% success rate for device implantation, with all patients discharged within 24 hours. Another study found that ICE had similar major complication rates to the traditional TEE method but resulted in fewer stomach-related issues. No deaths or serious complications were reported in these studies. This evidence suggests that ICE is safe and well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using intracardiac echocardiography (ICE) for left atrial appendage closure because it offers a less invasive method compared to the traditional transesophageal echocardiography (TEE). Unlike TEE, which requires general anesthesia and involves inserting a probe down the throat, ICE is performed internally via a catheter inserted through a vein, potentially reducing patient discomfort and recovery time. This method could make the procedure more accessible and comfortable for patients, which is why it’s generating interest and enthusiasm.

What evidence suggests that intracardiac echocardiography is effective for left atrial appendage closure?

This trial will compare intracardiac echocardiography (ICE) with traditional transesophageal echocardiography (TEE) for left atrial appendage closure (LAAC). Studies have shown that ICE performs as well as TEE for LAAC. In one study, both ICE and TEE successfully completed the procedure in about 98% of patients. Research suggests that ICE might be safer, with fewer issues like stomach problems compared to TEE. The ICE procedure had no major complications, though some patients experienced minor issues like bruising at the access site. Overall, ICE is a safe and effective alternative for guiding LAAC procedures. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12059760/

Intracardiac Echocardiography to Guide Left Atrial ... This review examines the comparative effectiveness, procedural advantages, limitations, and clinical outcomes of ICE and TEE in LAAO closure.

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)00082-1/fulltext

Left atrial appendage closure in patients ... - Heart Rhythm This study showed that LAAC with LAA thrombus using a LAmbre device guided by ICE may be feasible in selected patients regardless of the ...

3. jacc.org jacc.org/doi/10.1016/j.jacep.2019.11.014

Outcomes of Routine Intracardiac Echocardiography to ... Technical success was achieved in 97.8% and 97.4% of the patients in the ICE and TEE groups, respectively (p = 0.88). No patients in the ICE ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772930322005415

Feasibility and Safety of Intracardiac Echocardiography ... ICE-guided LAAC is safer than TEE-guided LAAC, with similar rates of major complications. However, ICE use was associated with lower rates of gastrointestinal ...

5. ahajournals.org ahajournals.org/doi/10.1161/jaha.116.003695

Left Atrial Appendage Closure Under Intracardiac ... There were no major procedural complications. The overall procedure‐related complication rate was 14.8%, mainly due to access site hematoma.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35210077/

Intracardiac Echocardiography-Guided Left Atrial ... This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by ...

7. jacc.org jacc.org/doi/10.1016/j.jcin.2025.01.371

700.25 Feasibility and Safety of 4D Intracardiac ... Successful device implant was achieved in 70 out of 72 patients (97.2%) and 100% of patients were discharged within 24 hours. 1 out of 72 ...

8. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00901-4/fulltext

PO-02-198 SAFETY AND FEASIBILITY OF ... PFA and LAAC were successful in all cases. The median (IQR) fluoroscopy and procedural duration were 15 min (12-19.5) and 133 min (122.5-161.5). No deaths, ...

9. ahajournals.org ahajournals.org/doi/10.1161/circ.150.suppl_1.4135286

Abstract 4135286: Comparative Efficacy of Intracardiac and ... Intracardiac Echocardiography (ICE) has been proven effective and safe for LAAO since 2011, yet adoption rates remain low, with only 2.2% of ...