VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF

NCT ID: NCT06383975

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2027-04-30

Brief Summary

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulsed field ablation with posterior wall isolation

Group Type: EXPERIMENTAL

Pulsed field ablation with posterior wall isolation

Intervention Type: PROCEDURE

Extended pulmonary vein isolation including posterior wall isolation using pulsed field ablation

Radiofrequency ablation and vein of Marshall ethanolization

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation and vein of Marshall ethanolization

Intervention Type: PROCEDURE

Radiofrequency pulmonary vein re-isolation (when necessary), vein of Marshall ethanol infusion with roof and mitral lines

Interventions

Pulsed field ablation with posterior wall isolation

Extended pulmonary vein isolation including posterior wall isolation using pulsed field ablation

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Sebastien Knecht

OTHER

Sponsor Role: lead

Responsible Party

Sebastien Knecht

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sébastien Knecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan Brugge AV

Locations

AZ Sint-Jan Brugge AV

Bruges, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Emma Christiaen

Role: CONTACT

emma.christiaen@azsintjan.be

003250453293

Facility Contacts

Emma Christiaen

Role: primary

emma.christiaen@azsintjan.be

Sébastien Knecht, MD, PhD

Role: backup

Other Identifiers

CIV-24-01-045634

Identifier Type: -

Identifier Source: org_study_id