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

Primary Purpose

Atrial Fibrillation

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

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

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

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.

Sites / Locations

  • Second Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

transesophageal echocardiography guidance

intracardiac echocardiography guidance

fluoroscopy only guidance

Arm Description

Outcomes

Primary Outcome Measures

injected contrast media
milliliter
fluoroscopy time were recorded
mGy

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2021
Last Updated
May 4, 2022
Sponsor
xieruiqin
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1. Study Identification

Unique Protocol Identification Number
NCT04833985
Brief Title
Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion
Official Title
Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

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

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 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.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transesophageal echocardiography guidance
Arm Type
Experimental
Arm Title
intracardiac echocardiography guidance
Arm Type
Experimental
Arm Title
fluoroscopy only guidance
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
LAAC combined with radiofrequency ablation
Intervention Description
Each patient received the same group of patients with simple radiofrequency ablation and LAAC
Primary Outcome Measure Information:
Title
injected contrast media
Description
milliliter
Time Frame
in the procedure
Title
fluoroscopy time were recorded
Description
mGy
Time Frame
in the procedure
Secondary Outcome Measure Information:
Title
the time from femoral vein puncture to transseptal puncture to closure were recorded
Description
second
Time Frame
in the procedure
Title
The size of the LAA
Description
millimeter
Time Frame
in the procedure
Title
the size of the selected umbrella in operation
Description
millimeter
Time Frame
in the procedure
Title
residual shunt and DRT after transcatheter closure of left atrial appendage detected
Description
Transesophageal echocardiography
Time Frame
before operation and 3 months after operation
Title
new pericardial effusion were detected
Description
Transthoracic echocardiography
Time Frame
3 months after operation
Title
pericardial tamponade were detected
Description
Transthoracic echocardiography
Time Frame
3 months after operation

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: 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.
Facility Information:
Facility Name
Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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