Comparison of Peri-procedural Complications of Intracardiac Echocardiography and Transesophageal Echocardiography in Patients With Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICE
TEE
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ICE group
TEE group
Arm Description
ICE group without TEE detection before procedure
TEE group with non-ICE usage at the entire procedure
Outcomes
Primary Outcome Measures
Procedure safety
Procedural-related complications of ICE and TEE.
Secondary Outcome Measures
Thrombus detection rate
Left atrial appendage thrombus detected by ICE and TEE.
Full Information
NCT ID
NCT05466266
First Posted
December 15, 2021
Last Updated
July 17, 2022
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
1. Study Identification
Unique Protocol Identification Number
NCT05466266
Brief Title
Comparison of Peri-procedural Complications of Intracardiac Echocardiography and Transesophageal Echocardiography in Patients With Atrial Fibrillation
Official Title
Comparison of Peri-procedural Complications of Intracardiac Echocardiography and Transesophageal Echocardiography in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICE group
Arm Type
Experimental
Arm Description
ICE group without TEE detection before procedure
Arm Title
TEE group
Arm Type
Active Comparator
Arm Description
TEE group with non-ICE usage at the entire procedure
Intervention Type
Device
Intervention Name(s)
ICE
Intervention Description
All patients received ICE examination.
Intervention Type
Device
Intervention Name(s)
TEE
Intervention Description
All patients received TEE examination.
Primary Outcome Measure Information:
Title
Procedure safety
Description
Procedural-related complications of ICE and TEE.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Thrombus detection rate
Description
Left atrial appendage thrombus detected by ICE and TEE.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Peri-procedural Complications of Intracardiac Echocardiography and Transesophageal Echocardiography in Patients With Atrial Fibrillation
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