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Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LAAC combined with radiofrequency ablation group
Sponsored by
Ruiqin xie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring transesophageal echocardiography, intracardiac echocardiography, left atrial appendage closure combined with radiofrequency ablation, atrial fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

sustained 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, 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.

Sites / Locations

  • Second Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

transesophageal echocardiography guidance

intracardiac echocardiography guidance

Arm Description

Outcomes

Primary Outcome Measures

injected contrast media as well as fluoroscopy time were recorded
injected contrast media as well as fluoroscopy time were recorded in all patients
the time from femoral vein puncture to transseptal puncture to closure were recorded
the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients
residual shunt and DRT after transcatheter closure of left atrial appendage detected
Transesophageal echocardiography
new pericardial effusion, pericardial tamponade were detected
Transthoracic echocardiography

Secondary Outcome Measures

Full Information

First Posted
May 13, 2020
Last Updated
May 4, 2022
Sponsor
Ruiqin xie
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1. Study Identification

Unique Protocol Identification Number
NCT04391504
Brief Title
Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation
Official Title
Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruiqin xie

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
A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography respectively (allocation ratio 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 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]), and renal failure requiring dialysis. The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided left atrial appendage occlusion combined with radiofrequency ablation. And try to analyze whether intracardiac echocardiography can be used as an alternative to transesophageal echocardiography in transcatheter closure of left atrial appendage. The average follow-up time was 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
transesophageal echocardiography, intracardiac echocardiography, left atrial appendage closure combined with radiofrequency ablation, atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography respectively (allocation ratio 1:1).
Masking
ParticipantOutcomes Assessor
Masking Description
The researchers will participate in the operation to record operative parameters. Other researchers including follow-up personnel and the ultrasonic data analyst are uninformed about the random situation of the patients (patient information is recorded according to the random number.Random numbers corresponding to the random allocation list are stored in the research center. After follow-up of the last patient is completed, the random allocation list is published by the random number designer; and the designer does not participate in the data collection and statistics.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transesophageal echocardiography guidance
Arm Type
Experimental
Arm Title
intracardiac echocardiography guidance
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
LAAC combined with radiofrequency ablation group
Intervention Description
Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
Primary Outcome Measure Information:
Title
injected contrast media as well as fluoroscopy time were recorded
Description
injected contrast media as well as fluoroscopy time were recorded in all patients
Time Frame
in the procedure
Title
the time from femoral vein puncture to transseptal puncture to closure were recorded
Description
the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients
Time Frame
in the procedure
Title
residual shunt and DRT after transcatheter closure of left atrial appendage detected
Description
Transesophageal echocardiography
Time Frame
1-12months
Title
new pericardial effusion, pericardial tamponade were detected
Description
Transthoracic echocardiography
Time Frame
1-12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: sustained 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, 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.
Facility Information:
Facility Name
Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China

12. IPD Sharing Statement

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Intracardiac Versus Transesophageal Echocardiography for Left Atrial Appendage Occlusion Combined With Radiofrequency Ablation

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