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

NCT06383975 | Recruiting

• 1 other identifier: CIV-24-01-045634
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial tachyarrhythmia recurrence within 12 months

  Percentage of patients with any atrial tachyarrhythmia recurrence (\> 30 sec) from 2 months (blanking period) to 12 months after the ablation procedure

  2-12 months

Secondary Outcomes (7)

• Safety and procedural related adverse event

  During procedure-12 months

• Duration of the ablation procedure

  During procedure

• Fluoroscopy time

  During procedure

• Fluoroscopy dose

  During procedure

• Effect of the procedure on quality of life

  3, 6, 9, 12 months

Study Arms (2)

Pulsed field ablation with posterior wall isolation

EXPERIMENTAL

Procedure: Pulsed field ablation with posterior wall isolation

Radiofrequency ablation and vein of Marshall ethanolization

ACTIVE COMPARATOR

Procedure: Radiofrequency ablation and vein of Marshall ethanolization

Interventions

Pulsed field ablation with posterior wall isolation PROCEDURE

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

Pulsed field ablation with posterior wall isolation

Radiofrequency ablation and vein of Marshall ethanolization PROCEDURE

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

Radiofrequency ablation and vein of Marshall ethanolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sebastien Knecht: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

AZ Sint-Jan Brugge AV

Bruges, 8000, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Sébastien Knecht, MD, PhD

  AZ Sint-Jan Brugge AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Christiaen

CONTACT

003250453293; emma.christiaen@azsintjan.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 25, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)