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Prospective, Randomized Controlled Clinical Study Protocol of Marshall Vein Ablation in Patients with Left Atrial Substrate Dysfunction Atrial Fibrillation

Prospective, Randomized Controlled Clinical Study Protocol of Marshall Vein Ablation in Patients with Left Atrial Substrate Dysfunction Atrial Fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088682
Enrollment
Unknown
Registered
2024-08-23
Start date
2024-08-31
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Atrial Fibrillation

Interventions

Marshall Intervention Group :For patients in the Marshall vein intervention group, if the left atrial substrate is good, the surgical endpoint is to achieve pulmonary vein electrical isolation and to
Non-Marshall Intervention Group (Conventional Ablation Group):"For patients randomly assigned to the non-Marshall vein intervention group, if the left atrial substrate is good, the surgical endpoint i

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the criteria for atrial fibrillation (AF) radiofrequency ablation and are scheduled for their first AF radiofrequency ablation; 2. Aged between 50 and 80 years; 3. Understand and support this study, and have signed the informed consent form; Patients are able to complete this study according to the research protocol requirements, including surgery and follow-up visits, etc.

Exclusion criteria

Exclusion criteria: 1. Atrial fibrillation caused by reversible factors, such as untreated hyperthyroidism; 2. Severe organic heart disease (e.g., severe mitral stenosis or regurgitation, severe aortic valve stenosis or regurgitation, hypertrophic obstructive cardiomyopathy, etc.); 3. Presence of thrombus or tumor in the atria; 4. Known severe progressive diseases (e.g., malignant tumors) or diseases that cause extreme exhaustion in patients, 5. Life expectancy of less than 12 months; 6. Absolute contraindications to the use of heparin or oral anticoagulation therapy; 7. Moderate to severe liver dysfunction (ALT or AST more than twice the upper limit of normal); 8. Severe renal insufficiency, with a creatinine clearance rate of less than 30 ml/min; 9. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Long-term AF/AT Recurrence Rate;

Secondary

MeasureTime frame
The impact of Marshall vein alcohol ablation on the occurrence of atrial arrhythmias during the blanking period after atrial fibrillation radiofrequency ablation, the mitral isthmus (MI) block rate, and the ablation time.;

Countries

China

Contacts

Public ContactZhang Chaoqun

Affiliated Hospital of Xuzhou Medical University

zhangchaoqun@medmail.com+86 516 8580 6230

Outcome results

None listed

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