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Status unknownNCT05466266Updated Jul 20, 2022

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

An interventional study of ICE and TEE in Atrial Fibrillation, sponsored by Shanghai Chest Hospital. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    ICE group

    ICE group without TEE detection before procedure

    Device: ICE

  • Active comparator
    TEE group

    TEE group with non-ICE usage at the entire procedure

    Device: TEE

Interventions

  • DeviceICE

    All patients received ICE examination.

  • DeviceTEE

    All patients received TEE examination.

06

What researchers measure

Primary outcomes

  1. Procedure safety

    Procedural-related complications of ICE and TEE.

    Time frame: 18 months

Secondary outcomes

  1. Thrombus detection rate

    Left atrial appendage thrombus detected by ICE and TEE.

    Time frame: 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05466266
Lead sponsor
Shanghai Chest Hospital
Collaborators
Sir Run Run Shaw Hospital, Beijing Chao Yang Hospital, First Affiliated Hospital of Suzhou Medical College, Qilu Hospital of Shandong University, RenJi Hospital, The First Affiliated Hospital with Nanjing Medical University, Qianfoshan Hospital
Responsible party
Xu Liu (Professor, Shanghai Chest Hospital) — Principal investigator
First posted
Jul 20, 2022
Start date
Aug 1, 2022 (estimated)
Primary completion
Aug 1, 2023 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Jul 20, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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