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Establishment of Active Monitoring and Safety/Effectiveness Evaluation Indices for Innovative Cardiac Arrhythmia Interventional Devices

Establishment of Active Monitoring and Safety/Effectiveness Evaluation Indices for Innovative Cardiac Arrhythmia Interventional Devices

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116717
Enrollment
Unknown
Registered
2026-01-14
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

Sponsors

Sun Yate-sen Memorial Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Over 18 years old; (2) Patients diagnosed with atrial fibrillation according to the "Chinese Guidelines for the Diagnosis and Treatment of Atrial Fibrillation" and have indications for radiofrequency ablation or left atrial appendage occlusion; (3) Voluntarily participate in this study and sign the informed consent form; (4) Willing to follow the relevant requirements of this trial and cooperate in completing the corresponding follow-up.

Exclusion criteria

Exclusion criteria: (1) The patient is unable or unwilling to comply with the study protocol and complete follow-up. (2) The patient is participating in other clinical trials and it may affect the data collection of this study. (3) The investigator deems there are other circumstances that make the patient unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Pre-discharge Device-Related Adverse Events;Therapeutic Success;Thromboembolic Event;

Secondary

MeasureTime frame
Adverse Events Related to the Device or Procedure During Follow-up;Technical Success;Successful Post-procedural Occlusion;

Countries

China

Contacts

Public ContactZhou Shuxian

Sun Yate-sen Memorial Hospital of Sun Yat-sen University

zhoushux@mail.sysu.edu.cn+86 20 8133 2360

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026