About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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%.
Trial design
Parallel
Treatments tested in this trial
Anterior Mitral Line Ablation
Procedure/SurgeryFirst pulmonary vein isolation (PVI) is performed - either as a first-time isolation (index procedure) or a re-isolation (in repeat procedures). Then a linear lesion is created on the anterior wall of the left atrium, from the roof line to the mitral annulus.
Posterior Mitral Isthmus Ablation with Vein of Marshall Ethanol Infusion
Procedure/SurgeryPulmonary vein isolation (PVI) is systematically carried out before any additional ablation lines are created - either as initial isolation or re-isolation. In this group the posterior mitral isthmus, a region between the left inferior pulmonary vein and the mitral annulus, is targeted. Endocardial ablation using a dual energy catheter (RF and PF) is combined with ethanol infusion in the vein of Marshall (VOM), which ablates the adjacent epicardial tissue to enhance lesion durability.
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with procedural linear bidirectional block
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.
Secondary outcomes
Procedural safety
Characterization of complications, including pericardial effusion, stroke and coronary stenosis
Procedural parameters: total procedure time (min)
Comparison of procedural parameters between groups: total procedure time (min)
Procedural parameters: fluoroscopy time (min)
Comparison of procedural parameters between groups: fluoroscopy time (min)
Procedural parameters: total RF ablation time (min)
Comparison of procedural parameters between groups: total RF ablation time
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: