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Clinical study of the new technique of cryosurgery combined with radiofrequency ablation in maze procedure for atrial fibrillation

Clinical study of the new technique of cryosurgery combined with radiofrequency ablation in maze procedure for atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035467
Enrollment
Unknown
Registered
2020-08-12
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Atrial fibrillation

Interventions

Experimental group:Cryotherapy combined with radiofrequency ablation for maze IV procedure
control group:Radiofrequency ablation for maze IV procedure

Sponsors

Xinhua Hospital Affiliated to Medical College of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with mitral valve disease requiring surgical treatment and a history of paroxysmal / persistent atrial fibrillation (evidence includes any of the following: atrial fibrillation was recorded by Holter or 12 lead ECG); 2. Patients who are willing to participate in the study, follow-up trials and evaluation procedures with informed consent; 3. Patients aged 18-80 years.

Exclusion criteria

Exclusion criteria: 1. Patients who have had previous atrial fibrillation ablation or cardiac surgery; 2. Patients with other organic heart diseases: Patients with other severe valvular disease, congenital heart disease, coronary heart disease and dilated cardiomyopathy except for mitral valve disease, who need other cardiac surgery except atrial fibrillation ablation at the same time; 3. Patients with other serious arrhythmias; 4. Patients with EF 65mm; 6. Malignant tumor, active infection, pregnant or lactating objects; 7. Patients with life expectancy less than 1 year; 8. Patients with hyperthyroidism; 9. Patients with other hemorrhagic diseases who can not be treated with anticoagulant therapy; 10. Patients with poor general condition and multiple organ dysfunction who are expected to be unable to tolerate surgery; 11. Patients who are not expected to complete the follow-up; 12. Patients who are unwilling or unable to comply with the study protocol; 13. Patients considered by other researchers to be unsuitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
rhythm;

Secondary

MeasureTime frame
Atrial flutter;Atrial tachycardia;Heart rate;Left heart function;Rate of withdrawal from antiarrhythmic drugs;Stroke;Systemic embolism;Heart failure;Rehospitalization rate;

Countries

China

Contacts

Public ContactJu Mei

Xinhua Hospital Affiliated to Medical College of Shanghai Jiaotong University

ju_mei63@126.com+86 13801669185

Outcome results

None listed

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