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The safety and efficacy of empirical superior vena cava electrical isolation on paroxysmal atrial fibrillation in Chinese patients: A multicenter randomized, single-blind controlled trial

The safety and efficacy of empirical superior vena cava electrical isolation on paroxysmal atrial fibrillation in Chinese patients: A multicenter randomized, single-blind controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055545
Enrollment
Unknown
Registered
2022-01-11
Start date
2021-05-01
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Atrial Fibrillation

Interventions

CPVI+SVCI group:Circumferential Pulmonary Veins Isolation (CPVI) + Superior Vena Cava Electrical Isolation (SVCI)
CPVI group:Circumferential Pulmonary Veins Isolation (CPVI)

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Diagnosed as paroxysmal atrial fibrillation; 3. Willing to sign an informed consent; 4. Willing to undergo surgery and follow-up.

Exclusion criteria

Exclusion criteria: 1. Previous atrial fibrillation catheter radiofrequency ablation (except paroxysmal supraventricular tachycardia); 2. Patients with thrombocytopenia (PLT = 55mm (2d echocardiography, parasternal long axis view); 4. Left atrial thrombus (by transesophageal ultrasound or MSCT); 5. Severe structural heart disease (e.g. moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe valvular heart disease); 6. Thyroid dysfunction; 7. Severe hepatic and renal dysfunction (AST or ALT >= 3 times the normal upper limit; SCR > 3.5 mg/dl or CCR < 30 ml/min); 8. History of nearly 3 months of surgical operations; 9. Pregnant women; 10.Life expectancy < 12 months.

Design outcomes

Primary

MeasureTime frame
The 1-year post-ablation success rate (no documented atrial fibrillation or other atrial arrhythmia events within 12 months).;

Secondary

MeasureTime frame
Perioperative complications (including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, septal nerve palsy, and death);Episodes of atrial arrhythmias (atrial fibrillation or atrial tachycardia) within 1 year after ablation;Rate and load of atrial tachycardia and/or frequent atrial premature in blank phase after ablation;Length of muscular sleeve and diameter of superior vena cava;

Countries

China

Contacts

Public ContactXu Wei, Shen Wenzhi

Nanjing Drum Tower Hospital

13390900868@163.com+86 13390900868

Outcome results

None listed

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