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Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation

Primary Purpose

Paroxysmal Supraventricular Tachycardia

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

About this trial

This is an interventional treatment trial for Paroxysmal Supraventricular Tachycardia focused on measuring paroxysmal supraventricular tachycardia, Left Atrial Function

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with paroxysmal supraventricular tachycardia,includes atrioventricular reentrant tachycardia and atrioventricular nodal reentrant tachycardia， Age is >14 years

Exclusion Criteria:

Atrial fibrillation, Atrial tachycardia， Structural heart disease, Ventricular arrhythmias, Patients with impaired left ventricular systolic function or on antiarrhythmics

Sites / Locations

  • The Second Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients with atrioventricular nodal reentrant tachycardia

patients with atrioventricular tachycardia

Arm Description

radiofrequency catheter ablation therapy

radiofrequency catheter ablation therapy

Outcomes

Primary Outcome Measures

Left Atrial Function of postoperative radiofrequency ablation.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2017
Last Updated
March 17, 2020
Sponsor
Ruiqin xie
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1. Study Identification

Unique Protocol Identification Number
NCT03348436
Brief Title
Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation
Official Title
Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (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
This study to investigate the effects of RF ablation on left atrial systolic function in patients with atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular tachycardia (AVRT).
Detailed Description
A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation. Left atrial systolic function was assessed using atrial ejection force (AEF) according to Manning's formula (AEF = 0.5 x ρ x MA x A(2), r: blood density = 1.06 g/cm(3), MA: mitral orifice area [cm(2)], A: A wave velocity). The following left atrial dimensions were assessed: antero-posterior (LA-AP), infero-superior (LA-IS, long axis), medio-lateral (LA-ML, short axis). The correlations between AEF and electrophysiological parameters were analysed (VA - ventriculo-atrial conduction, VA/CL - tachycardia cycle length).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Supraventricular Tachycardia
Keywords
paroxysmal supraventricular tachycardia, Left Atrial Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 100 patients with persistent，in whom successful RF ablation of slow pathway or accessory pathway was performed. Patients with atrial fibrillation, structural heart disease, ventricular arrhythmias, impaired left ventricular systolic function or on antiarrhythmics were excluded. All the patients had echocardiographic study before ablation 、1 day and 1 months after ablation.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with atrioventricular nodal reentrant tachycardia
Arm Type
Experimental
Arm Description
radiofrequency catheter ablation therapy
Arm Title
patients with atrioventricular tachycardia
Arm Type
Experimental
Arm Description
radiofrequency catheter ablation therapy
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Primary Outcome Measure Information:
Title
Left Atrial Function of postoperative radiofrequency ablation.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with paroxysmal supraventricular tachycardia,includes atrioventricular reentrant tachycardia and atrioventricular nodal reentrant tachycardia， Age is >14 years Exclusion Criteria: Atrial fibrillation, Atrial tachycardia， Structural heart disease, Ventricular arrhythmias, Patients with impaired left ventricular systolic function or on antiarrhythmics
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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Study on Left Atrial Function of Paroxysmal Supraventricular Tachycardia After Radiofrequency Ablation

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