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12-month follow-up study on the effectiveness and safety of cardiac electrophysiological interventional instrument control system combined with disposable electrophysiological interventional instrument support for assisted atrial fibrillation catheter ablation (Two-way, open, parallel positive control)-Beijing Anzhen Hospital Affiliated to Capital Medical University

12-month follow-up study on the effectiveness and safety of cardiac electrophysiological interventional instrument control system combined with disposable electrophysiological interventional instrument support for assisted atrial fibrillation catheter ablation (Two-way, open, parallel positive control)-Beijing Anzhen Hospital Affiliated to Capital Medical University

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089380
Enrollment
Unknown
Registered
2024-09-06
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Atrial fibrillation

Interventions

Experimental Group:None
Control group:None

Sponsors

Beijing Anzhen Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects who participated in the "Clinical Trial on the Short-term Efficacy and Safety of Cardiac Electrophysiological Interventional Device Control System Combined with Disposable Electrophysiological Interventional Device Support for Assisted Catheter Ablation of Atrial Fibrillation (Protocol Number: MAXC-CTO-HN-2021-0047)" and completed 3 months of follow-up after surgery were included. This study did not set additional inclusion and exclusion criteria.

Exclusion criteria

Exclusion criteria: Subjects who have not participated in the "Clinical Trial on the Short-term Effectiveness and Safety of Cardiac Electrophysiology Interventional Device Control System Combined with Disposable Electrophysiology Interventional Device Support for Assisted Atrial Fibrillation Catheter Ablation (Protocol Number: MAXCCTO-HN-2021-0047)" (this clinical trial is used to study the medical device registration application of the device, so it is referred to as the "Registration Clinical Trial") and completed the 3-month follow-up after surgery, including subjects in the experimental group and the control group

Design outcomes

Primary

MeasureTime frame
Postoperative recurrence rate;Atrial fibrillation quality of life;

Secondary

MeasureTime frame
Surgical complication rate;Adverse event rate;Incidence of serious adverse events;

Countries

CHINA

Contacts

Public ContactCAIHUA SANG

Beijing Anzhen Hospital Affiliated to Capital Medical University

sch9613070@sina.com+86 134 3908 0206

Outcome results

None listed

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