VOLT-AF IDE Clinical Study
Research type
Research Study
Full title
VOLT-AF IDE Clinical Study (ABT-CIP-10514; CRD-1034)
IRAS ID
337126
Contact name
Alessandra Denaro
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
Pulsed field ablation (PFA) for atrial fibrillation (irregular heartbeat) is a procedure that involves using a catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) to deliver a pulsed electrical field to one or more areas in the upper left chamber of the heart that is causing the irregular heartbeat. The pulsed electric field creates a small scar on the heart. This scar will block the electrical pathway that is causing the irregular heartbeat.
The use of catheter ablation to create small scars on the heart tissue to block electrical pathways causing irregular heart rhythms has been well established and used in clinical practice for many years to treat AF. Catheters and ablation systems that deliver different energy forms to create the small scars, including radiofrequency energy (a type of heat) and cryothermy (freezing), have previously been approved for use to treat AF. The Volt PFA system delivers a pulsed electric field to create the scar through a process called irreversible electroporation.
The Volt PFA system is made up of 4 main devices:
• Volt™ PFA Catheter, Sensor Enabled™
• Agilis™ NxT Steerable Introducer Dual-Reach™
• Volt™ PFA Generator
• EnSite™ X EP System with EnSite™ Pulsed Field Ablation ModuleThe purpose of this research study is to collect data to show that the Volt PFA System functions as intended in a clinical setting and to demonstrate acute safety and effectiveness for the treatment of symptomatic, recurrent, drug refractory paroxysmal and persistent atrial fibrillation (AF)
REC name
South East Scotland REC 02
REC reference
24/SS/0051
Date of REC Opinion
15 Aug 2024
REC opinion
Further Information Favourable Opinion