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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05466266
• Other study ID #: ICE VS TEE 2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: July 2022
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• ICE
All patients received ICE examination.
• TEE
All patients received TEE examination.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Beijing Chao Yang Hospital, First Affiliated Hospital of Suzhou Medical College, Qilu Hospital of Shandong University, RenJi Hospital, Shandong Provincial Qianfoshan Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure safety	Procedural-related complications of ICE and TEE.	18 months
Secondary	Thrombus detection rate	Left atrial appendage thrombus detected by ICE and TEE.	18 months