Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion

Overview

A total of 75 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into 3 groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography and fluoroscope only respectively (allocation ratio 1:1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. All patients underwent transesophageal echocardiography before and 3 months after operation, and the results were explained by two experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. All patients were examined by transthoracic echocardiography 3 months after operation to evaluate new pericardial effusion, pericardial tamponade, instrument embolization / displacement and so on. The baseline clinical and surgical features and hospitalization outcomes of patients guided by ICE and TEE and fluoroscopy only were recorded and compared. Clinical endpoints include death, new pericardial effusion that does not require pericardiocentesis, tamponade with pericardiocentesis, instrument embolism / displacement, bleeding at the entry site, thromboembolic events (stroke / transient ischemic attack [TIA]). The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided and fluoroscopy only-guided left atrial appendage occlusion combined with radiofrequency ablation. The average follow-up time is 3 months.

Full Title of Study: “Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2021

Interventions

  • Procedure: LAAC combined with radiofrequency ablation
    • Each patient received the same group of patients with simple radiofrequency ablation and LAAC

Arms, Groups and Cohorts

  • Experimental: transesophageal echocardiography guidance
  • Experimental: intracardiac echocardiography guidance
  • Experimental: fluoroscopy only guidance

Clinical Trial Outcome Measures

Primary Measures

  • injected contrast media
    • Time Frame: in the procedure
    • milliliter
  • fluoroscopy time were recorded
    • Time Frame: in the procedure
    • mGy

Secondary Measures

  • the time from femoral vein puncture to transseptal puncture to closure were recorded
    • Time Frame: in the procedure
    • second
  • The size of the LAA
    • Time Frame: in the procedure
    • millimeter
  • the size of the selected umbrella in operation
    • Time Frame: in the procedure
    • millimeter
  • residual shunt and DRT after transcatheter closure of left atrial appendage detected
    • Time Frame: before operation and 3 months after operation
    • Transesophageal echocardiography
  • new pericardial effusion were detected
    • Time Frame: 3 months after operation
    • Transthoracic echocardiography
  • pericardial tamponade were detected
    • Time Frame: 3 months after operation
    • Transthoracic echocardiography

Participating in This Clinical Trial

Inclusion Criteria

AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2 and HAS-BLED score ≥3, not suitable for long-term oral anticoagulant drugs. Exclusion Criteria:

Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • xieruiqin
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: xieruiqin, director of cardiology department – The Second Hospital of Hebei Medical University
  • Overall Contact(s)
    • Xie Ruiqin, 15803212537, 13230178060@163.com

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