VOLT CE Mark Study

• Research type

  Research Study

• Full title

  First in human study of the investigational Volt PFA System for atrial fibrillation

• IRAS ID

  333822

• Contact name

  Amber Miller

• Contact email

  amber.miller@abbott.com

• Sponsor organisation

  Abbott (St Jude Medical)

• Clinicaltrials.gov Identifier

  NCT00000000

• Duration of Study in the UK

  1 years, 7 months, 31 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 Module

  The Volt PFA System has gone through extensive testing in a laboratory setting to make sure it is safe to use and functions as it is expected to. This research study will be the first investigation to assess these characteristics when the Volt PFA System is used to treat humans. The 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 atrial fibrillation. This study will include a feasibility sub-study to confirm acute safety of the Volt PFA System in humans.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  23/LO/0997

• Date of REC Opinion

  25 Jan 2024

• REC opinion

  Further Information Favourable Opinion