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Pulmonary vein isolation only versus additional validated mitral isthmus bidirectional conduction block during catheter ablation for persistent atrial fibrillation: a prospective, multi-center, randomized control trial

Pulmonary vein isolation only versus additional validated mitral isthmus bidirectional conduction block during catheter ablation for persistent atrial fibrillation: a prospective, multi-center, randomized control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125382
Enrollment
Unknown
Registered
2026-05-26
Start date
2024-11-05
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Persistent Atrial Fibrillation

Interventions

MIL+ group:Pulmonary vein isolation plus mitral isthmus ablation
MIL- group:Pulmonary vein isolation

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age ranged from 30 to 80 years; 2.Persistent AF: duration of AF =6 months and < 5 years; Two random electrocardiograms and one Holter showed atrial fibrillation within six months before enrollment. Preoperative heart rhythm was atrial fibrillation; 3.Willing to sign an informed consent form; 4.Able to complete the study as required by the protocol;

Exclusion criteria

Exclusion criteria: 1. Paroxysmal atrial fibrillation; 2. The duration of AF was = 5 years; 3. Reversible causes of atrial fibrillation such as untreated hyperthyroidism; 4. Previous intervention for atrial fibrillation (including surgical maze procedure, catheter ablation, left atrial appendage occlusion, etc.); 5. Severe organic heart disease (such as severe mitral stenosis or regurgitation, severe aortic stenosis or regurgitation, hypertrophic obstructive cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, etc.); 6. Thrombus and tumor were present in the atrium; 7. Left atrium diameter > 55 mm; 8. Contraindications to the use of heparin or oral anticoagulation; 9. Creatinine clearance < 30 ml/min; 10. Pregnancy.

Design outcomes

Primary

MeasureTime frame
freedom from any documented atrial arrhythmia recurrence after a single procedure;

Secondary

MeasureTime frame
freedom from any documented atrial fibrillation recurrence after a single procedure;The incidence of complications during perioperative and follow-up;freedom from any documented atrial tachycardia recurrence after a single procedure;

Countries

China

Contacts

Public ContactSongwen Chen

Shanghai General Hospital

chensongwen@hotmail.com+86 21 6324 0050

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026