Comparison of Peri-procedural Complications of Intracardiac Echocardiography and Transesophageal Echocardiography in Patients With Atrial Fibrillation

NCT ID: NCT05466266

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-01

Brief Summary

Atrial fibrillation (AF) is the most common arrhythmia. Worldwide, the incidence of atrial fibrillation in men and women is 596.2 per 100,000 and 373.1 per 100,000, respectively. [1] The prevalence of AF in China is 0.97%.[2] AF increases the risk of stroke, heart failure and death. Ischemic stroke occurs in 25% of hospitalized patients with nonvalvular atrial fibrillation according to a single-center clinical study in China. [3,4] Complications associated with AF place a huge burden on the healthcare system, with an estimated 4.9 billion RMB for patients with AF in China, 89% of which are caused by AF-related strokes.[5]

According to the 2018 AHA/ACC/HRS guideline [6], catheter ablation was recommended for paroxysmal AF that is symptomatic and refractory or intolerable to at least one class I or III antiarrhythmic drug. Transesophageal echocardiography (TEE) is a necessary preoperative examination for catheter ablation of patients with AF in order to exclude thrombus in the left atrium and left atrial appendage (LAA) and to prevent thrombotic complications caused by thrombus shedding during the procedure. However, TEE detection, like gastroscopy, requires transpharyngeal insertion of the probe into the esophagus and should be fasted before it. The TEE probe is thicker than the gastroscope, which can increase the discomfort of the patient during the examination. At the same time, if the patient cooperates poorly during the delivery process, the probe may damage the oropharyngeal or esophageal mucosa, causing complications such as bleeding or perforation.

Intracardiac echocardiography (ICE) is a new technique that can completely replace TEE in excluding thrombus in left atrium and left atrial appendage. The advantages are that the catheter is inserted from the femoral vein without the discomfort of stimulating the swallowing reflex caused by TEE examination; To avoid complications such as bleeding or perforation caused by injury to oropharynx or esophageal mucosa; It can be used in frail, elderly, pharyngeal or esophageal lesions (eg, ulcers, varices), or intolerable patients. Some studies have shown that ICE is an important test for the diagnosis of LAA thrombosis, especially when thrombus is described as a soft thrombus.

TEE is the gold standard for the detection of thrombi in the LAA before catheter ablation for AF. ICE is used to assist AF ablation; however, ICE is also accurate for LAA visualization and minimizes the complications during procedures[7].

The primary purpose of this study aimed at determining whether ICE could replace TEE by minimizing the procedural-related complications but not compromise the detection of thrombi in the LAA.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

ICE group

ICE group without TEE detection before procedure

Group Type: EXPERIMENTAL

ICE

Intervention Type: DEVICE

All patients received ICE examination.

TEE group

TEE group with non-ICE usage at the entire procedure

Group Type: ACTIVE_COMPARATOR

TEE

Intervention Type: DEVICE

All patients received TEE examination.

Interventions

ICE

All patients received ICE examination.

Intervention Type: DEVICE

TEE

All patients received TEE examination.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Aged 18-80 years.

2. Willing to sign informed consent.

3. Patients diagnosed with atrial fibrillation Paroxysmal AF and Persistent AF according to the latest clinical guidelines.

Exclusion Criteria

1. End-stage disease with a mean life expectancy less than 1 year

2. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction less than 30%

3. Previous surgical or catheter ablation for AF

4. Bradycardia and presence of implanted ICD

5. Uncontrolled hypertension: Systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) > 110 mmHg

6. Patients with Cardiovascular events including acute myocardial infarction, any PCI, valvular cardiac surgical, or percutaneous procedure within the past 3 months

7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study

8. Have been enrolled in an investigational study evaluating devices or drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Suzhou Medical College

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Hu X, Jiang W, Wang X, Ye P, Li X, Wang Y, Zheng Q, Wang Y, Leng L, Zhang Z, Han B, Zhang Y, Qin M, Liu X, Hou X; ICE vs TEE Study Investigators. Intracardiac vs Transesophageal Echocardiography in Atrial Fibrillation Ablation: A Randomized Clinical Trial. JAMA Cardiol. 2025 Oct 8:e253687. doi: 10.1001/jamacardio.2025.3687. Online ahead of print.

Reference Type: DERIVED

PMID: 41060665 (View on PubMed)

Other Identifiers

ICE VS TEE 2021

Identifier Type: -

Identifier Source: org_study_id