Study of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population

Atrial Fibrillation Clinical Trial

— CONTROL-AF  

Official title:

Application of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population in the Northern Shanghai Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311137
• Other study ID #: CONTROL-AF
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: January 1, 2032

Study information

• Verified date: May 2022
• Source: Shanghai 10th People's Hospital
• Contact: DongDong Zhao, PhD
• Phone: +86 18917684008
• Email: zhaodd[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy.

Description:

This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy, the improvement of disease outcome and the economic value of the atrial fibrillation population in the northern Shanghai community. Improve the disease cognition of patients with atrial fibrillation, and promote the development of the concept of closed-loop treatment of atrial fibrillation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 1, 2032
• Est. primary completion date: January 1, 2024
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• atrial fibrillation patients;Ability to act autonomously, understand and sign informed consent;

Exclusion Criteria:

• none(All patients with atrial fibrillation were enrolled in this study indiscriminately and followed up)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Radiofrequency ablation
Combined use of radiofrequency ablation, cryoablation, left bundle branch pacing, and left atrial appendage closure according to the actual situation of the patient.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation recurrence	The recurrence of atrial fibrillation and the degree of burden of atrial fibrillation in patients.	2 years
Primary	Heart failure	Degree of heart failure (including EF%, NYHA score, etc.)	5 years
Primary	Stroke	stroke attack(Check for new cerebral infarction by MRI)	5 years
Secondary	bleeding	major bleeding event	2 years
Secondary	Cardiovascular MACE events	Cardiovascular MACE events	5 years