High-density Mapping-guided bOx Isolation and subsTrate Ablation

Atrial Fibrillation Clinical Trial

— HOT  

Official title:

Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03998956
• Other study ID #: 3rdxiangya@csu
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Remodeling

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