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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03998956
Other study ID # 3rdxiangya@csu
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date August 31, 2021

Study information

Verified date June 2019
Source The Third Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Informed consent signed.

- Age of 18 to 75 years old.

- Persistent or longstanding persistent atrial fibrillation (=7 days), which is confirmed by Holter in recent six months.

- Willing to have catheter ablation for atrial fibrillation.

Exclusion Criteria:

- Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.

- Complete atrioventricular block.

- An acute stroke or contradiction of anti-coagulation.

- Hyperthyroidism.

- Having a history of catheter ablation of atrial fibrillation.

- Left atrial appendage thrombosis confirmed by transesophageal echocardiography.

- Pregnancy or lactation.

- Planning for pregnancy in the near future.

- Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.

- Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CPVI
Circumferential PV isolation only
CPVI+BOX
Circumferential PV and BOX isolation
CPVI+BOX+SUB
Atrial substrate ablation apart from circumferential PV and BOX isolation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Third Xiangya Hospital of Central South University

Outcome

Type Measure Description Time frame Safety issue
Primary sinus rhythm maintenance rate Holter is performed 12months after the procedure and heart rhythm is recorded. 12 months
Secondary left ventricular ejection fraction LVEF is evaluated by echocardiography 12months after the procedure. 12 months
Secondary Stroke or embolic events History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed. 12 months
Secondary Atrial fibrosis Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis. 1 day
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