Skip to content

The safety and efficacy of cryoballoon catheter ablation in the treatment of persistent atrial fibrillation: a prospective, multicentre, randomized controlled study

The safety and efficacy of cryoballoon catheter ablation in the treatment of persistent atrial fibrillation: a prospective, multicentre, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036636
Enrollment
Unknown
Registered
2020-08-24
Start date
2021-01-21
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

atril fibrillaiton

Interventions

Group 1:Pulmonary vein isolation catheter ablation
Group 2:Pulmonary vein isolation catheter ablation plus linear ablation on the left roof plus or not plus focal ablation outside the pulmonary vein

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Multiple consecutive ecg and Holter tests within 3 months before ablation confirmed full AF; (2) PersAF patients with a duration of more than 7 days and less than 1 year; (3) Aged 18-75 years; (4) Agreed to participate in this study, had understanding ability and signed informed consent, and had good clinical compliance to complete the postoperative clinical follow-up as required by the program.

Exclusion criteria

Exclusion criteria: (1) The diameter of the left atrium >= 50mm; (2) Severe organic heart disease, including moderate to severe valvular insufficiency or stenosis, previous myocardial infarction, and congenital heart disease; (3) Left ventricular ejection fraction < 40%; (4) patients who have undergone coronary artery bypass grafting in the past 3 months or implanted coronary stent within 1 year; (5) NYHA III or IV heart failure; (6) Severe respiratory insufficiency, such as chronic obstructive pulmonary disease, bronchiectasis, and bronchial asthma; (7) patients who have undergone left atrial ablation or surgical treatment for atrial fibrillation; (8) Thrombosis in the left atrium or cloudy echo in the atrium; (9) Known bleeding tendency, or intolerance to heparin or warfarin anticoagulation; (10) Those who participate in other clinical research trials and have not yet reached the main clinical endpoint; (11) Pregnant women; (12) Life expectancy less than 1 year with other serious diseases.

Design outcomes

Primary

MeasureTime frame
recurring rate of AF;

Countries

China

Contacts

Public ContactWu Liqun

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

wuliqun89@Hotmail.com+86 13801621534

Outcome results

None listed

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