Ablation techniques for persistent atrial fibrillation in heart failure patients
Clinical Study on the 2C3L Strategy Based on Marshall Venous Chemoablation for the Treatment of Persistent Atrial Fibrillation Combined With Heart Failure
This study is testing a new heart procedure to see if it can help people with persistent atrial fibrillation and heart failure feel better and restore a normal heart rhythm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06438692 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a novel 2C3L ablation strategy combined with VOM ethanol chemical ablation for patients suffering from persistent atrial fibrillation and heart failure. Utilizing advanced electroanatomical mapping and specific ablation parameters, the study aims to achieve effective isolation of pulmonary veins and improve patient outcomes. The intervention involves a single catheter procedure targeting specific areas of the heart to restore normal rhythm and alleviate symptoms associated with atrial fibrillation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with persistent atrial fibrillation and a left ventricular ejection fraction (LVEF) of 40% or less, who have not responded to antiarrhythmic medications.
Not a fit: Patients with paroxysmal atrial fibrillation or those whose condition is secondary to reversible causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart function and quality of life for patients with persistent atrial fibrillation and heart failure.
How similar studies have performed: Other studies have shown promising results with similar ablation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age:18y-80y 2. First ablation on non valvular atrial fibrillation 3. Persistent atrial fibrillation with LVEF≤40% 4. The patient has symptoms related to atrial fibrillation, including but not limited to palpitations, premonitory syncope, syncope, fatigue, and shortness of breath, and is evaluated for clinical cardiac function between NYHA II-IV levels 5. No response to antiarrhythmic drugs, unacceptable side effects, or unwillingness to take antiarrhythmic drugs. Exclusion Criteria: 1. Paroxysmal atrial fibrillation 2. Atrial fibrillation secondary to obvious reversible causes 3. Echocardiography: Parasternal long axis section, left atrial diameter ≥ 60mm 4. LVEF \>40% 5. Receiving dual antithrombotic therapy 6. Contraindications to the use of oral anticoagulants 7. Contraindications to right or left cardiac catheterization 8. pregnancy 9. Life expectancy\<1 year (such as advanced malignant tumors, advanced kidney disease, etc.) 10. Unable to discontinue antiarrhythmic drugs due to reasons other than atrial fibrillation
Where this trial is running
Jinan, Shandong
- Hesheng Hu — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Hesheng Hu
- Email: hyperhhs@163.com
- Phone: 13589112300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.