VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulsed field ablation with posterior wall isolation, Radiofrequency ablation and vein of Marshall ethanolization.
- Who it may be relevant to
- Registry conditions: Persistent Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between VEin of MArshall Ethanol Infusion Versus Extended Pulmonary Vein PULSEd Field Ablation After Failed Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation
Overview
The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat. The main question the trial aims to answer is: • Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure? Participants will: * Undergo an ablation with either the new or the standard technique * Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up * Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit * Record their heart rhythm at home every week * Complete a questionnaire 3, 6, 9 and 12 months after the procedure
Detailed description
Background
Pulmonary vein isolation (PVI) remains the cornerstone of catheter ablation for the treatment of atrial fibrillation (AF). However, in patients with persistent AF, recurrence occurs in 20% to 50% of the patients. These patients often need additional ablation beyond PVI in the index procedure or in a redo procedure. During redo procedures, optimal management of AF has not been validated yet. Different strategies are used but without strong scientific background and without uniformity.
In the case of PV reconnection, PV re-isolation alone seems to be the gold standard in healthy atria, but with moderate success in patients with dilated left atrium or scar zones.
Different recent studies show a potential impact of posterior wall isolation; however with discordant results. This could be in part related to low rate of durable posterior wall isolation and also due to potential risk of esophageal fistula limiting the use of RF ablation at the posterior wall. The use of pulsed field energy could improve lesion durability and avoid any risk of fistula.
On the other hand, ethanol infusion in the vein of Marshal has also been shown to improve the success rate of persistent AF ablation but requires significant experience and may be time-consuming.
Rationale
Currently, there are no clear ablation endpoints in the case of AF recurrence post PVI. Especially for patients with persistent AF since substrate ablation beyond PVI does not seem to improve the success rate during a first procedure. However, this could be related to inappropriate patient selection. Indeed, PVI-resistant patients present those with worst prognosis with respect to AF recurrence. Additionally, when durable PVI is observed following recurrence in patients with persistent AF, case ablation beyond PVI seems reasonable and necessary.
The aim of this trial is to compare two strategies with clear endpoints, to avoid potential bias. The gold standard, PVI, is also respected in both groups In one group, PFA re-isolation of PVs and of the posterior wall has the advantage of a clear straight forward approach, with short-lasting procedures and which does not require high level technical skills.
In the second group, radiofrequency guided PV re-isolation will be performed in combination with mitral, aided by vein of Marshall ethanol infusion, and dome lines until bidirectional block. A Vein of Marshall is present in \~90% of the patients and strongly facilitates block at the mitral line (almost 100%) while a dome transection reduces the risk of further left atrial tachyarrhythmia.
Hypothesis
The hypothesis of this study is that the efficacy of a straightforward strategy of PV re-isolation (if necessary) and additional posterior wall isolation using the PFA FARAPULSETM catheter is comparable to that of a more complex and time consuming RF strategy aiming at vein of Marshall ethanol infusion and linear lesions at the roof and at the mitral line.
Design
This is a prospective, randomized (1:1), open label, blinded endpoint study (PROBE). Eligible subjects, who sign the study informed consent form, with persistent AF will be randomized into one of two study arms. In the pulsed field ablation (PFA) arm, patients will be treated using the FARAPULSETM catheter, aiming at pulmonary vein (PV) re-isolation (if necessary) and isolation of the posterior wall. In the radiofrequency (RF) group, patients will receive ethanol infusion in the vein of Marshall, followed by re-isolation of the PV (if necessary), dome and mitral lines with aim at bidirectional block.
Interventions
- Procedure Pulsed field ablation with posterior wall isolation
Extended pulmonary vein isolation including posterior wall isolation using pulsed field ablation - Procedure Radiofrequency ablation and vein of Marshall ethanolization
Radiofrequency pulmonary vein re-isolation (when necessary), vein of Marshall ethanol infusion with roof and mitral lines
Primary outcome measures
- Atrial tachyarrhythmia recurrence within 12 months [Time frame: 2-12 months]
Secondary outcome measures (7)
- Safety and procedural related adverse event [Time frame: During procedure-12 months]
- Duration of the ablation procedure [Time frame: During procedure]
- Fluoroscopy time [Time frame: During procedure]
- Fluoroscopy dose [Time frame: During procedure]
- Effect of the procedure on quality of life [Time frame: 3, 6, 9, 12 months]
- Incidence of repeat ablation [Time frame: 12 months]
- Unscheduled visits and hospitalization [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Symptomatic persistent atrial fibrillation (AF) despite a first PVI. Persistent AF is defined as the presence of AF lasting ≥7 days (i.e. in case of new onset AF one has to wait for 7 days)
Exclusion criteria
- Persistent AF lasting ≥ 12 months
- Advanced valvular heart disease
- Left atrial (LA) volume >150mL
- LA diameter (PS-LAX) >60mm
- Septal wall diameter >15mm
- Life expectancy <1 year
- Weight >150 kg
- Any contra indication to catheter ablation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- AZ Sint-Jan Brugge AV — Bruges
Identifiers
NCT: NCT06383975 · CIV-24-01-045634