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

NCT05466266 | Unknown

• 1 other identifier: ICE VS TEE 2021
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Procedure safety

  Procedural-related complications of ICE and TEE.

  18 months

Secondary Outcomes (1)

• Thrombus detection rate

  18 months

Study Arms (2)

ICE group

EXPERIMENTAL

ICE group without TEE detection before procedure

Device: ICE

TEE group

ACTIVE COMPARATOR

TEE group with non-ICE usage at the entire procedure

Device: TEE

Interventions

ICE DEVICE

All patients received ICE examination.

ICE group

TEE DEVICE

All patients received TEE examination.

TEE group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-80 years.
• Willing to sign informed consent.
• Patients diagnosed with atrial fibrillation Paroxysmal AF and Persistent AF according to the latest clinical guidelines.

You may not qualify if:

• End-stage disease with a mean life expectancy less than 1 year
• New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction less than 30%
• Previous surgical or catheter ablation for AF
• Bradycardia and presence of implanted ICD
• Uncontrolled hypertension: Systolic blood pressure (SBP) \>180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg
• Patients with Cardiovascular events including acute myocardial infarction, any PCI, valvular cardiac surgical, or percutaneous procedure within the past 3 months
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study
• Have been enrolled in an investigational study evaluating devices or drugs.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Sir Run Run Shaw Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• First Affiliated Hospital of Suzhou Medical College: collaborator
• Qilu Hospital of Shandong University: collaborator
• RenJi Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Qianfoshan Hospital: collaborator

Related Publications (1)

• 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 Dec 1;10(12):1249-1256. doi: 10.1001/jamacardio.2025.3687.

  PMID: 41060665 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: July 20, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share