- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04833985
Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion
Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China
- Second Hospital of Hebei Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: transesophageal echocardiography guidance
|
Each patient received the same group of patients with simple radiofrequency ablation and LAAC
|
Experimental: intracardiac echocardiography guidance
|
Each patient received the same group of patients with simple radiofrequency ablation and LAAC
|
Experimental: fluoroscopy only guidance
|
Each patient received the same group of patients with simple radiofrequency ablation and LAAC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
injected contrast media
Time Frame: in the procedure
|
milliliter
|
in the procedure
|
fluoroscopy time were recorded
Time Frame: in the procedure
|
mGy
|
in the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the time from femoral vein puncture to transseptal puncture to closure were recorded
Time Frame: in the procedure
|
second
|
in the procedure
|
The size of the LAA
Time Frame: in the procedure
|
millimeter
|
in the procedure
|
the size of the selected umbrella in operation
Time Frame: in the procedure
|
millimeter
|
in the procedure
|
residual shunt and DRT after transcatheter closure of left atrial appendage detected
Time Frame: before operation and 3 months after operation
|
Transesophageal echocardiography
|
before operation and 3 months after operation
|
new pericardial effusion were detected
Time Frame: 3 months after operation
|
Transthoracic echocardiography
|
3 months after operation
|
pericardial tamponade were detected
Time Frame: 3 months after operation
|
Transthoracic echocardiography
|
3 months after operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEE vs.ICE vs.fluoroscopy only
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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