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

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT06383975

Run by

Sebastien Knecht

People needed

100

Starts

2024-05-15

Expected to finish

2027-04-30

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• AZ Sint-Jan Brugge AV — Bruges, Belgium (enrolling)

Full record on ClinicalTrials.gov

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