Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 146
- 主要终点
- Number of patients with procedural linear bidirectional block
研究概览
简要总结
The goal of this clinical study is to find out which treatment works best for people with persistent atrial fibrillation (a type of irregular heartbeat). Researchers are comparing two types of heart ablation procedures:
- An anterior mitral line ablation (a treatment at the front part of the heart)
- A posterior mitral line ablation (at the back of the heart), sometimes with an extra step using a small vein called the Vein of Marshall
The main questions the study aims to answer are:
- Which approach works better at fixing the heart rhythm?
- Which approach is safer (less complications)?
People who take part in this study will:
- Undergo an ablation procedure as part of their standard care
- Attend follow-up visits at 1, 3, and 6 months
- Have tests like ECGs, heart ultrasound (echocardiogram), blood tests, heart rhythm monitors (Holter), and a heart CT scan
详细描述
The MIVANT trial aims to compare two different strategies for treating patients with persistent atrial fibrillation (AF) using catheter ablation techniques. AF is a common heart rhythm disorder, and in persistent forms, it often does not respond adequately to pulmonary vein isolation (PVI) alone. For this reason, many patients require additional ablation lines in the left atrium to reduce arrhythmia recurrence and improve long-term rhythm control.
One such ablation strategy involves creating a linear lesion across the mitral isthmus-a region between the mitral valve and the pulmonary veins. There are two main anatomical approaches to target this area:
- The anterior mitral line, which connects the right superior pulmonary vein to the mitral annulus
- The posterior mitral line, which connects the left inferior pulmonary vein to the mitral annulus
The posterior line is technically more challenging because of the complex anatomy, proximity to blood vessels, and epicardial electrical pathways that can bypass endocardial lesions. However, this difficulty can be addressed by a technique known as Vein of Marshall (VOM) ethanol infusion. The VOM is a small vein near the mitral isthmus that contains nerve fibers and muscle bundles involved in atrial arrhythmias. Infusing ethanol into this vein can help create more effective and lasting ablation lines by reaching areas that standard catheter ablation cannot.
The MIVANT study will enroll 146 adult patients with persistent atrial fibrillation who are already scheduled to receive additional ablation beyond PVI. Patients will be randomized in a 1:1 ratio to undergo either:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 and 80 years, diagnosed with symptomatic persistent AF with clinical indication for left atrial ablation with a mitral isthmus line. Pulmonary vein will be isolated in all patients before starting the mitral isthmus line (during a previous or the same procedure)
排除标准
- •Previous mitral line or any other left atrial ablation beyond pulmonary vein isolation
- •Left atrial (LA) thrombus. LA thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI.
- •LA diameter greater than 60 mm on long axis parasternal view, or left atrial volume more than 250 cc.
- •Left ventricular ejection fraction <25%.
- •Cardiac surgery within the previous 90 days.
- •Expecting cardiac transplantation or other cardiac surgery within 180 days.
- •Percutaneous transluminal coronary angioplasty/stenting or myocardial infarction within the previous 30 days.
- •Documented history of a thromboembolic event within the previous 60 days.
- •Diagnosed atrial myxoma.
- •Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- •Women who are pregnant or who plan to become pregnant during the study.
- •Acute illness or active infection at time of index procedure
- •Renal insufficiency
- •Unstable angina.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation.
- •Life expectancy less than 1 year.
- •Uncontrolled heart failure.
- •Presence of a condition that precludes vascular access.
- •International normalised ratio (INR) greater than 4 within 24 hours of procedure - for patients taking warfarin.
- •Unwilling or unable to provide informed consent.
结局指标
主要结局
Number of patients with procedural linear bidirectional block
时间窗: During procedure
After first-pass ablation, bidirectional block across the mitral isthmus line will be assessed by conventional methods consisting of differential pacing maneuvers and documenting widely separated double potentials across the entire length of the line and high-density activation mapping with the Optrell catheter. In the case of absence of block, PF applications will be carried out on the RF line where the earliest activation will be evidenced, for an target index of \>550. In the case of absence of block after PF ablation, additional RF and PF ablation points will be performed at the earliest activation sites, adjacent to the previous lesions. A maximum total duration of RF and PF application of 20 min will be allowed for both lines, after which the failure of block will be accepted. Bidirectional conduction block will be reassessed ≥10min after the last ablation lesion along the lines.
次要结局
- Left atrial function at 6 months follow-up(6 months)
- Procedural safety(6 months)
- Procedural parameters: total procedure time (min)(During procedure)
- Procedural parameters: fluoroscopy time (min)(During procedure)
- Procedural parameters: total RF ablation time (min)(During procedure)
- Procedural parameters: total ablation time (min)(During procedure)
- Procedural parameters: number of ablation lesions required(During procedure)
- Cardiovascular-related hospitalizations(6 months)
- Recurrence of arrhythmia(6 months)
- Quality of life (SF-36 and AF Symtoms Checklist)(6 months)
研究者
Sebastien Knecht
Coordinating investigator
AZ Sint-Jan AV