Study of the Closed-loop Treatment Concept of Atrial Fibrillation in the Atrial Fibrillation Population (CONTROL-AF)

May 20, 2022 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Atrial fibrillation patients in North Shanghai area.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Closed-loop Group
Groups of Patients Adhering to Closed-Loop Therapy.
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.
Other Names:
  • cryoablation;
  • left bundle branch pacing;
  • left atrial appendage occlusion;
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
Combined use of radiofrequency ablation, cryoablation, left bundle branch pacing, and left atrial appendage closure according to the actual situation of the patient.
Other Names:
  • cryoablation;
  • left bundle branch pacing;
  • left atrial appendage occlusion;

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding
Time Frame: 2 years
major bleeding event
2 years
Cardiovascular MACE events
Time Frame: 5 years
Cardiovascular MACE events
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Investigators

  • Study Chair: WeiYa Xu, PhD, No. 301 Yanchang Middle Road, Jing'an District, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2032

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONTROL-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Radiofrequency ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe