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The efficacy of catheter ablation combined with Marshall vein ethanol infusion in persistent atrial fibrillation and its effect on cardiac remodeling

The efficacy of catheter ablation combined with Marshall vein ethanol infusion in persistent atrial fibrillation and its effect on cardiac remodeling

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093218
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Persistent atrial fibrillation

Interventions

Combined Ablation Group: Marshall Vein Ethanol Infusion + CPVI (Circumferential Pulmonary Vein Isolation) + Left Atrial Roofline Ablation + Left Atrial Bottom Line Ablation:Initially, perform Marshall
then proceed with pacing to verify the presence of mitral isthmus block. If a mitral isthmus block is confirmed, sequentially perform CPVI, left atrial roofline ablation, and left atrial bottom line a
Single catheter ablation group: CPVI + left atrial roof line ablation + left atrial bottom line ablation:Sequential CPVI, left atrial roofline ablation, and left atrial bottom line ablation.

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: - Symptomatic persistent atrial fibrillation (AF) confirmed by routine 12-lead electrocardiogram or 24-hour Holter monitoring, with a duration of more than 7 days but less than 3 years (diagnosed according to the **2020 ESC Guidelines for the Diagnosis and Management of Atrial Fibrillation**). - Male and female patients aged 18 to 75 years. - Patients requiring catheter ablation due to persistent arrhythmia despite using antiarrhythmic drugs for more than 6 weeks. - Patients with no evidence of thrombus in the atrium or left atrial appendage, as confirmed by transesophageal echocardiography (TEE). - Patients who voluntarily decide to participate in the study and provide written informed consent. - Patients able to understand, follow instructions, and participate throughout the study period.

Exclusion criteria

Exclusion criteria: - Paroxysmal atrial fibrillation; - Patients who have previously undergone atrial fibrillation ablation or maze surgery; - Patients who have undergone cardiac surgery within the past 3 months; - Patients diagnosed with acute coronary syndrome within the past 3 months, or who have received stent implantation or coronary artery bypass grafting in the proximal coronary arteries along the anticipated surgical pathway at the time of the study; - Patients with severe heart failure or cardiogenic shock; - Patients with hypertrophic cardiomyopathy; - Patients with contraindications to contrast agents or anticoagulants; - Patients with imaging examinations (CT, TEE, or MRI) within the past month confirming the presence of thrombus in the atrium or left atrial appendage; - Patients with evidence of atrial thrombus; - Patients with malignant intracardiac tumors; - Patients with an expected life expectancy of 12 months or less; - Patients with severe renal insufficiency (creatinine clearance <30 ml/min); - Pregnant women, breastfeeding mothers, and women planning to conceive or who may become pregnant during the study but are not using medically acceptable contraceptive measures; - Patients with chronic symptomatic restrictive or chronic obstructive pulmonary disease; - Patients with acute illness or active infection; - Patients with a history of coagulation or bleeding disorders; - Patients with contraindications to anticoagulation; - Patients with diseases that impair vascular access; - Patients who have participated in other clinical trials within 30 days prior to screening; - Patients unwilling or unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Incidence of Atrial Arrhythmias Within 12 Months Post-Surgery;

Countries

China

Contacts

Public ContactShuyan Li

The First Hospital of Jilin University

Lixb94@163.com+86 135 9605 2348

Outcome results

None listed

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