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Evaluation of Efficiency and Durability of Ethanol Infusion in the Vein of Marshall on the Acute Reconnection After Mitral Isthmus Bi-Directional Block

Evaluation of Efficiency and Durability of Ethanol Infusion in the Vein of Marshall on the Acute Reconnection After Mitral Isthmus Bi-Directional Block

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052243
Enrollment
Unknown
Registered
2021-10-23
Start date
2020-04-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Atrial Fibrillation

Interventions

EIVOM group:EIVOM+CPVA+MI+CTI+Roofline+intra-CS ablation
RFCA group:CPVA+MI+CTI+Roofline+intra-CS ablation

Sponsors

Beijing Anzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients must meet all the following criteria to be included in the study: 1. Aged between 18 and 85 years; 2. patients undergoing a first-time ablation procedure for AF; 3. Symptomatic persistent AF with history no more than five years; 4. Refractory to at least one class I, II, or III AAD; 5. Willingness, ability and commitment to participate in follow-up evaluations.

Exclusion criteria

Exclusion criteria: Patients are to be excluded if any of the following criteria is met 1. LA thrombus as measured by pre-procedure TEE or CT; 2. LA diameter greater than 55 mm on long axis parasternal view; 3. Rheumatic valvular heart disease; 4. Myocardial infarction or stroke within 3 months of screening; 5. Uncontrolled congestive heart failure or ejection fraction <35% as measured by echocardiography; 6. Significant congenital heart disease; 7. Significant valvular disease and/or prosthetic heart valve(s); 8. Coronary artery bypass graft surgery within 1 year of screening; 9. Contraindication to anticoagulation; 10. Pulmonary emboli within 1 year of screening; 11. Severe electrolyte abnormalities within 1 month of treatment; 12. Pregnancy; 13. Any contraindication to right or left sided heart catheterization; 14. Poor general health; 15. Life expectancy less than 1 year; 16. Allergy to contrast media; 17. Cannot be removed from antiarrhythmic drugs for reasons other than AF; 18. Unwilling or unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
The Rate of Acute Conduction Recovery 30 Minutes After MI Bi-directional Block;

Secondary

MeasureTime frame
The Rate of MI Bi-directional Block;The Approach of MI Block (First-pass Block or Non First-pass Block);The Gap Location of Conduction Recovery After MI Bi-directional Block;Discharge Time on MI Ablation (s);Total Procedural Time (From Atrial Septal Puncture Successfully) (min);The Rate of Acute Conduction Recovery 30 Minutes After Bilateral Pulmonary Vein Isolation, Respectively;Discharge Time on RPV Ablation and LPV Ablation, Respectively (s);Fluoroscopy time of Each Group (s);Complications Related to EIVOM and RFCA, Respectively;The Rate of AF/AFL/AT-Free Suvial After 1-year Follow-up;

Countries

China

Contacts

Public ContactMa Changsheng

Beijing Anzhen Hospital

chshma@vip.sina.com+86 10 64456372

Outcome results

None listed

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