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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
Shanghai Chest Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    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
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    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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