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A randomized, controlled clinical study assessing the effectiveness of nifekaline hydrochloride and amiodarone hydrochloride in the maintenance of sinus rhythm after radiofrequency ablation therapy for atrial fibrillation concomitant with valve replacement surgery

A randomized, controlled clinical study assessing the effectiveness of nifekaline hydrochloride and amiodarone hydrochloride in the maintenance of sinus rhythm after radiofrequency ablation therapy for atrial fibrillation concomitant with valve replacement surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039611
Enrollment
Unknown
Registered
2020-11-03
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-08

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

Conditions

Maintenance of sinus rhythm after radiofrequency ablation therapy for atrial fibrillation concomitant with valve replacement surgery

Interventions

control group:amiodarone hydrochloride

Sponsors

Department of Cardiovascular Surgery, Shandong Provincial Hospital affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Those who are 18 or younger; 2. Those with 45 kg <= body weight <= 100 kg; 3. Those subjects with 3 hours <= new onset AF / AF time <= 48 hours after cardiovascular surgery.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindication of anticoagulation; 2. The objects of taboo of law conversion; 3. Subjects with hemodynamic instability; 4. Subjects of acute coronary syndrome; 5. Patients with QRS greater than 0.14 seconds or ventricular rate less than 50 beats / min without pacemaker; 6. Patients who have used class I or class III antiarrhythmic drugs within 24 hours; 7. Patients with QTc interval greater than 0.480s in females and 0.470s in males; 8. Patients with NYHA cardiac function grade IV; 9. Patients with diastolic blood pressure lower than 60mmhg or systolic blood pressure lower than 95mmhg; 10. Subjects with blood potassium < 3.5mmol/l; 11. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
maintenance of sinus rhythm after radiofrequency ablation therapy for atrial fibrillation concomitant with valve replacement surgery;

Countries

China

Contacts

Public ContactHaizhou Zhang

Department of cardiovascular surgery, provincial hospital affiliated to Shandong First Medical University

zhz_doctor@163.com+86 15168889333

Outcome results

None listed

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