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

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Radiofrequency ablation

• Registration Number: NCT05311137
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-05
• Status Verified: 2022-05
• Study Start: 2022-05-01
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-24
• Primary Completion: 2024-01-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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）

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exchange Group	Radiofrequency ablation	Groups of patients with delayed compliance with closed-loop therapy for atrial fibrillation.
Closed-loop Group	Radiofrequency ablation	Groups of Patients Adhering to Closed-Loop Therapy.

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation recurrence	2 years	The recurrence of atrial fibrillation and the degree of burden of atrial fibrillation in patients.
Stroke	5 years	stroke attack(Check for new cerebral infarction by MRI）
Heart failure	5 years	Degree of heart failure (including EF%, NYHA score, etc.)

Secondary Outcome Measures

Name	Time	Method
bleeding	2 years	major bleeding event
Cardiovascular MACE events	5 years	Cardiovascular MACE events

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China