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A randomized controlled study on the safety and effectiveness of low-frequency tragus vagus nerve stimulation in pulmonary vein isolation in patients with paroxysmal atrial fibrillation

A randomized controlled study on the safety and effectiveness of low-frequency tragus vagus nerve stimulation in pulmonary vein isolation in patients with paroxysmal atrial fibrillation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054789
Enrollment
Unknown
Registered
2021-12-27
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-12-05

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

Conditions

Atrial fibrillation

Interventions

Group 2:tragus vagus nerve stimulation

Sponsors

Jinshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1. No gender restriction, aged 18 to 78 years; 2. Atrial fibrillation terminated by itself or by intervention within 7 days after the onset; 3. Voluntarily participate and sign the informed consent form, promise to abide by the research procedures, and cooperate with the implementation of the whole process of research.

Exclusion criteria

Exclusion criteria: 1. Secondary to electrolyte imbalance or thyroid disease; 2. Severe valve disease or prosthetic valve replacement; 3. Myocardial infarction or cardiac surgery within 3 months; 4. Stroke or transient ischemic attack within 6 months; 5. Left ventricular ejection fraction less than 35%; 6. The anterior and posterior diameter of the left atrium is greater than 55mm; 7. Left atrial appendage or left atrial mural thrombus; 8. Contraindication of warfarin, heparin or allergy to contrast medium; 9. Other abnormalities cause unacceptable catheter operation; 10. Pregnant women and lactating women; 11. Third-degree atrioventricular block.

Design outcomes

Primary

MeasureTime frame
Ablation success rate;

Countries

China

Contacts

Public ContactPeng Fei

Jinshan Hospital Affiliated to Fudan University

fpeng13@fudan.edu.cn+86 18930815532

Outcome results

None listed

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