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

NCT05311137 | Recruiting DMC

• 1 other identifier: CONTROL-AF
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation；closed-loop treatment；

Outcome Measures

Primary Outcomes (3)

• Atrial fibrillation recurrence

  The recurrence of atrial fibrillation and the degree of burden of atrial fibrillation in patients.

  2 years

• Heart failure

  Degree of heart failure (including EF%, NYHA score, etc.)

  5 years

• Stroke

  stroke attack(Check for new cerebral infarction by MRI）

  5 years

Secondary Outcomes (2)

• bleeding

  2 years

• Cardiovascular MACE events

  5 years

Study Arms (3)

Closed-loop Group

Groups of Patients Adhering to Closed-Loop Therapy.

Procedure: Radiofrequency ablation

No Closed-loop Group

Patients who have not undergone closed-loop treatment or patients who have not undergone standard surgery and medication.

Exchange Group

Groups of patients with delayed compliance with closed-loop therapy for atrial fibrillation.

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

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

Also known as: cryoablation;, left bundle branch pacing;, left atrial appendage occlusion;

Closed-loop Group; Exchange Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Atrial fibrillation patients in North Shanghai area.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation; Cryosurgery; Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Cardiac Catheterization; Catheterization; Investigative Techniques

Study Officials

• WeiYa Xu, PhD

  No. 301 Yanchang Middle Road, Jing'an District, Shanghai, China

  STUDY CHAIR

Central Study Contacts

DongDong Zhao, PhD

CONTACT

+86 18917684008; zhaodd@tongji.edu.cn

Jun Zhang, MD

CONTACT

+86 15000420881; zhangjun_njmu2011@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Director of Cardiovascular Medicine

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: May 1, 2022
• Primary Completion: January 1, 2024
• Study Completion (Estimated): January 1, 2032
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)