Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

Launched by R&D CARDIOLOGIE · Jun 7, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation," is studying a new method for treating atrial fibrillation (AF), a heart condition that causes an irregular heartbeat. The trial will investigate whether using a new technology called pulsed field ablation (PFA) can help patients experience fewer episodes of AF compared to traditional methods. PFA uses electrical energy to create precise lesions in heart tissue to block abnormal signals that cause AF. The goal is to see if delivering more targeted treatments can improve outcomes for patients.

To participate in this study, individuals must be scheduled for a specific type of heart procedure called pulmonary vein isolation (PVI) with a special catheter system and should have a history of either paroxysmal atrial fibrillation (AF that comes and goes) or persistent AF that has been managed with medication. Unfortunately, certain health conditions and recent medical procedures may prevent someone from joining the trial. Participants can expect to receive the new treatment and be closely monitored to assess how well it works. Overall, this trial aims to enhance the effectiveness of AF treatment and improve patients' quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND
• • Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR
• • Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past
• Exclusion Criteria:
• • Cerebrovascular accident (CVA) in the last 6 months
• • More than moderate valvular disease that would require intervention
• • Cardiac catheter/surgical intervention in the last 3 months or scheduled
• • Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
• • Left atrial appendage (LAA) closure in the past
• • Mechanical mitral valve
• • Non-adherence to oral anticoagulation in the 3 weeks prior to ablation
• • Renal disease with known eGFR\<45 ml
• • Left atrial volume index (LAVI) \>50 ml/m2 or left atrial diameter (LAD) \>50 mm
• • Known contra-indication for catheter ablation
• • Known contra-indication for deep sedation or general anesthesia
• • Known pregnancy