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NCT Number: NCT05311137

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

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

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location status: Recruiting

Location contact

Jun Zhang, M.D.

CONTACT

[email protected]

+8615000420881

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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）

Treatment and study plan

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.

Other names: cryoablation;, left bundle branch pacing;, left atrial appendage occlusion;

Primary outcomes

  1. Atrial fibrillation recurrence

    Time frame: 2 years

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

  2. Heart failure

    Time frame: 5 years

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

  3. Stroke

    Time frame: 5 years

    stroke attack(Check for new cerebral infarction by MRI）

Secondary outcomes

  1. bleeding

    Time frame: 2 years

    major bleeding event

  2. Cardiovascular MACE events

    Time frame: 5 years

    Cardiovascular MACE events

Study contacts

Contact information is provided by the study sponsor or research team.

DongDong Zhao, PhD

CONTACT

[email protected]

+86 18917684008

Jun Zhang, MD

CONTACT

[email protected]

+86 15000420881

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Acronym: CONTROL-AF

Important dates

Study start
2022
Primary completion
2024
Study completion
2032
First posted
Apr 5, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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