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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
ChiCTR2400089812
Enrollment
Unknown
Registered
2024-09-18
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Paroxysmal atrial fibrillation

Interventions

Experimental Group:None
Control group:None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18 =age = 75 years old, regardless of gender; (2) Subjects confirmed to have paroxysmal atrial fibrillation by surface electrocardiogram [considering the characteristics of paroxysmal atrial fibrillation, previous atrial fibrillation electrocardiograms were accepted, with no restrictions on the examination time and examination institution, and the researchers judged whether the previous electrocardiograms met the requirements.], and subjects who had participated in the "Clinical Trial of the Short-term Effectiveness and Safety of Cardiac Electrophysiological Interventional Device Control System Combined with Disposable Electrophysiological Interventional Device Support for Assisted Atrial Fibrillation Catheter Ablation (Protocol Number: MAXC-CTO-HN-2021-0047)" and completed 3-month follow-up after surgery; (3) Subjects or their guardians were able to understand the purpose of the study, showed sufficient compliance with the study protocol, and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who have undergone atrial and ventricular surgery within 4 weeks before surgery; (2) Patients who have undergone heart valve replacement surgery; (3) Patients who have undergone unsuccessful or recurrent catheter ablation in the past; (4) Patients with systemic infection; (5) Patients with thromboembolic diseases; (6) Patients with intracardiac thrombus or atrial myxoma; (7) Patients with cardiac and great vessel tumors; (8) Left ventricular ejection fraction (LVEF) = 40%; (9) Patients with NYHA heart function class III-IV; (10) Patients with stroke or other cerebrovascular diseases within 3 months before surgery; (11) Patients who cannot tolerate or cooperate with the surgery; (12) Pregnant or lactating women; (13) Participated in other interventional drug, biological agent or device clinical trials within 1 month before screening; (14) Other situations judged by the investigator to be unsuitable for inclusion.

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 ContactFangyi Xiao

The First Affiliated Hospital of Wenzhou Medical University

harry686896@126.com+86 135 6628 6896

Outcome results

None listed

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