Skip to content

Pulmonary vein isolation only versus additional validated mitral isthmus bidirectional conduction block during catheter ablation for persistent atrial fibrillation: a prospective, multicenter, randomized control trial (MI-AF study)

Pulmonary vein isolation only versus additional validated mitral isthmus bidirectional conduction block during catheter ablation for persistent atrial fibrillation: a prospective, multicenter, randomized control trial (MI-AF study)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037210
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Atrial Fibrillaton

Interventions

experimental group:mitral isthmus liner ablation plus PVI
control group:PVI

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 30 to 80 years ; 2. AF lasting 6 months to 5 years; Two random electrocardiograms and one 24h holter in the half year before enrollment indicate atrial fibrillation.Atrial fibrillation was detected preoperatively. 3. Agree and sign informed consent; 4. Patients must be willing and able to comply with all peri-ablation and follow-up requirements.

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation caused by reversible causes, such as untreated hyperthyroidism; 2. Previous surgery due to atrial fibrillation, whether cardiac surgery or percutaneous interventional procedure (including surgical maze operation, catheter ablation and left atrial appendage occlusion procedure, etc.); 3. Severe organic heart disease (such as severe mitral stenosis or reflux, severe aortic valve stenosis or reflux, hypertrophic obstructive cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, etc.); 4. Existence of thrombus and tumor in the atrium; 5. The anteroposterior diameter of left atrium > 55mm (2D echocardiography, long axis view beside sternum); 6. Contra-indication to heparin or oral anticoagulant therapy; 7. Creatinine clearance < 30ml/min; 8. Pregnant women; 9. Novel Coronavirus infected patients.

Design outcomes

Primary

MeasureTime frame
Freedom from documented AF/AT episodes > 30 seconds at 12 months after one ablation procedure without antiarrhythmic medications, 3 months after ablation is a blank period.;

Secondary

MeasureTime frame
Procedure time;Fluoroscopy time;Ablation time;Freedom from documented AF episodes > 30 seconds at 12 months after one ablation procedure without antiarrhythmic medications;Freedom from documented AT episodes > 30 seconds at 12 months after one ablation procedure without antiarrhythmic medications;Relationship of acute AF termination to long-term procedural outcome;

Countries

China

Contacts

Public ContactShaowen Liu

Shanghai General Hospital

shaowen.liu@hotmail.com+86 13817825235

Outcome results

None listed

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