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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089418
Enrollment
Unknown
Registered
2024-09-09
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Atrial fibrillation

Interventions

Control group:None
Experimental Group:None

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Subjects who have participated in the "Clinical Trial on the Short-term Efficacy and Safety of Cardiac Electrophysiology Interventional Device Control System Combined with Disposable Electrophysiology Interventional Device Support for Assisted Catheter Ablation of Atrial Fibrillation (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 the operation, including subjects in the experimental group and the control group.

Exclusion criteria

Exclusion criteria: None

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 ContactGenqing Zhou

Shanghai General Hospital

genqing.zhou@hotmail.com+86 138 1862 1005

Outcome results

None listed

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