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Prospective randomized controlled study of Cryoballoon Ablation of RooF line combined with pulmonary vein Isolation for persistent atrial fibrillation

Cryoballoon Ablation of RooF line combined with pulmonary vein Isolation for persistent atrial fibrillation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039746
Enrollment
Unknown
Registered
2020-11-07
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

Atrial Fibrillation

Interventions

pulmonary vein isolation (Group PVI):cryoballoon ablation of pulmonary vein isolation
cryoballoon ablation of roof line combined with pulmonary vein isolation (Group RL):cryoballoon ablation of roof line combined with pulmonary vein isolation

Sponsors

Department of Cardiovasology, Changhai Hospitai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Symptomatic non-valve atrial fibrillation, and symptoms appear when there is electrocardiograph, holter monitor or random electrocardiograph, with duration between 7 days and 3 years. 2. Refractory to at least one class I or class III antiarrhythmic drug. 3. Age between 18 and 80 years old. 4. Patients who are aware of the advantages and disadvantages of radiofrequency ablation and cryoballoon ablation. 5. Participants or legal representatives of whom understand and have the willingness to write informed consent and participant in the trial.

Exclusion criteria

Exclusion criteria: 1. Thrombosis in the left atrium or left atrial appendage; 2. Left atrial diameter over 50mm; 3. With high possibility of bleeding or contraindication of anticoagulant drugs; 4. With a history of stroke or myocardial infarction in 3 months; 5. Uncontrolled hyperthyroidism; 6. Pregnancy; 7. The expected lifetime less than one year; 8. Cryoglobulinemia; 9. Severe lung function decline (with a history of COPD); 10. Abnormal thyroid function.

Design outcomes

Primary

MeasureTime frame
survival rate with no atrial fibrillation;

Countries

China

Contacts

Public ContactCao Jiang

Department of Cardiovasology, Changhai Hospitai

chrfca@163.com+86 21-31161262

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026