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Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by Multimodal Echocardiographic Techniques

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiofrequency ablation (RFCA)
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Right atrium, Echocardiography, Remodeling

Eligibility Criteria

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

Inclusion Criteria:

  1. With a history of paroxysmal Af (PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings: AF lasting for ≥30 s recorded in Holter or 12-lead ECG.
  2. No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment.
  3. Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.
  4. Aged 18-80 years.

Exclusion Criteria:

  1. With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;
  2. In the list of heart transplantation;
  3. Expected survival less than 1 year;
  4. With other hemorrhagic diseases and anticoagulant therapy is not allowed;
  5. Thrombosis in left atrium;
  6. Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)<40%;
  7. Patients with uncontrolled cancer;
  8. Significant hepatic or renal impairment (and/or alanine transaminase(ALT) or Aspartate transaminase(AST) >2 times upper limit of normal, creatinine clearance rate(CCr)<50%);
  9. Previous catheter radiofrequency ablation for AF or cardiac surgery;
  10. Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.

Sites / Locations

  • Xinhua Hospital,Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients with AF

Assigned Comparisons

Arm Description

Before radiofrequency ablation (RFCA)

After radiofrequency ablation (RFCA)

Outcomes

Primary Outcome Measures

Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients

Secondary Outcome Measures

Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography

Full Information

First Posted
April 15, 2016
Last Updated
December 16, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02838914
Brief Title
Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by Multimodal Echocardiographic Techniques
Official Title
Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by by Multimodal Echocardiographic Techniques for Atrial Fibrillation Patients Before and After Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (RFCA)
Detailed Description
The prevalence of atrial fibrillation (AF) has increased in recent years. The construction and function of right atrium haven't shown clearly before and after radiofrequency ablation (RFCA).The purpose of the study is to investigate whether RFCA can lead to inverse reconstruction of right atrium for atrial fibrillation patients, which diagnosing by speckle tracking echocardiography combined with real-time three dimensional echocardiography. All patients will be followed up for 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Right atrium, Echocardiography, Remodeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with AF
Arm Type
Experimental
Arm Description
Before radiofrequency ablation (RFCA)
Arm Title
Assigned Comparisons
Arm Type
Experimental
Arm Description
After radiofrequency ablation (RFCA)
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation (RFCA)
Intervention Description
Patients undergo radiofrequency ablation (RFCA)
Primary Outcome Measure Information:
Title
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time Frame
In one week before RFCA
Secondary Outcome Measure Information:
Title
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time Frame
In one week after RFCA
Title
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time Frame
At three months after RFCA
Title
Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
Time Frame
At six months after RFCA
Title
Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography
Time Frame
In one week after RFCA
Other Pre-specified Outcome Measures:
Title
Adverse events that are related to RFCA, such as the incidence of pulmonary vein stenosis(%) and embolism(%) were obtained by CT
Time Frame
At six months after RFCA

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: With a history of paroxysmal Af (PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings: AF lasting for ≥30 s recorded in Holter or 12-lead ECG. No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment. Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures. Aged 18-80 years. Exclusion Criteria: With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction; In the list of heart transplantation; Expected survival less than 1 year; With other hemorrhagic diseases and anticoagulant therapy is not allowed; Thrombosis in left atrium; Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)<40%; Patients with uncontrolled cancer; Significant hepatic or renal impairment (and/or alanine transaminase(ALT) or Aspartate transaminase(AST) >2 times upper limit of normal, creatinine clearance rate(CCr)<50%); Previous catheter radiofrequency ablation for AF or cardiac surgery; Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Sun, M.D.;Ph.D.
Phone
13651696395
Email
sunkunxh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yu, M.D.
Phone
13817308128
Email
yuyi20122012@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Sun, M.D.;Ph.D.
Organizational Affiliation
Department of Ultrasound, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Sun, M.D.;Ph.D
Phone
13651696395
Email
Sunkunxh@163.com
First Name & Middle Initial & Last Name & Degree
Yi Yu, M.D.
Phone
13817308128
Email
yuyi20122012@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by Multimodal Echocardiographic Techniques

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