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

December 16, 2018 updated by: Yi Yu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by by Multimodal Echocardiographic Techniques for Atrial Fibrillation Patients Before and After Radiofrequency Ablation

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital,Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: patients with AF
Before radiofrequency ablation (RFCA)
Procedure: radiofrequency ablation (RFCA)
Patients undergo radiofrequency ablation (RFCA)
EXPERIMENTAL: Assigned Comparisons
After radiofrequency ablation (RFCA)
Procedure: radiofrequency ablation (RFCA)
Patients undergo radiofrequency ablation (RFCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
In one week before RFCA

Secondary Outcome Measures

Outcome Measure
Time Frame
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
In one week after RFCA
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
At three months after RFCA
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
At six months after RFCA
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
In one week after RFCA

Other Outcome Measures

Outcome Measure
Time Frame
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
At six months after RFCA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Kun Sun, M.D.;Ph.D., Department of Ultrasound, Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

July 17, 2016

First Posted (ESTIMATE)

July 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 16, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Paroxysmal Atrial Fibrillation

Clinical Trials on radiofrequency ablation (RFCA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe