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

Condition(s) studied

Investigational drug(s) / intervention(s)

Pulsed field ablation with posterior wall isolation: Extended pulmonary vein isolation including posterior wall isolation using pulsed field ablation

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

Study 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

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

More Sebastien Knecht trials in Belgium

Other trials for the same condition