Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy

NACompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

September 28, 2023

Primary Completion Date

April 18, 2025

Study Completion Date

April 18, 2025

Conditions
Atrial Fibrillation, Paroxysmal or PersistentAtrial Fibrillation and FlutterAtrial Flutter Typical
Interventions
DEVICE

VARIPULSE™ catheter ablation

"Subjects will arrive to the electrophysiology laboratory for their ablation procedure and will undergo preparation for the procedure per standard protocol.~The purpose of an ablation procedure is to scar or destroy the heart tissue causing the atrial fibrillation. The current FDA approved ablation treatments commonly use freezing, radio frequency, or laser, delivered through a catheter that is threaded through blood vessels to the heart, as the energy source to destroy the abnormal tissue.~The BWI IRE VARIPULSE ablation system used in this study uses a type of energy source called pulse field.~Pulse field ablation applies ultra-rapid (less than 1 second) electrical fields to the heart muscle to destroy the abnormal tissue. This type of energy is thought to safer and more effective at treating atrial fibrillation.~● For a lesion set that cannot be performed using the VARIPULSE catheter technology, a conventional FDA-approved RF ablation"

Trial Locations (1)

10029

Icahn School of Medicine at Mount Sinai, New York

All Listed Sponsors
lead

Vivek Reddy

OTHER

NCT06056557 - Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy | Biotech Hunter | Biotech Hunter