VICTORY AF
Research type
Research Study
Full title
Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation (VICTORY AF) ablation study, prospective,multi-center,investigational, global, clinical study
IRAS ID
131470
Contact name
Stephen Murray
Contact email
Sponsor organisation
Medtronic, Inc.
Clinicaltrials.gov Identifier
Research summary
The VICTORY AF Study is a prospective, single arm, multi-centre, investigational, global, clinical study. The study is being conducted to confirm the safety risk of procedure and/or device related strokes in subjects with history of symptomatic persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the phased radio frequency (RF) system.\nThe Medtronic Phased RF System is intended to be used for mapping intracardiac electrograms and to deliver precise, temperature controlled radio frequency ablation therapy within the left atrium of the heart for the treatment of atrial fibrillation. The System includes the GENius Multi Channel Radio Frequency Ablation Generator and four anatomically designed, multi-electrode catheters -Pulmonary Vein Ablation Catheter (PVAC) or Pulmonary Vein Ablation Catheter GOLD (PVAC GOLD, the Multi-Array Septal Catheter (MASC), and the Multi-Array Ablation Catheter (MAAC) Catheter System.\n\nThe Phased RF ablation catheter is placed in areas that are believed to cause AF and will heat the area to destroy the abnormal tissue. Once the tissue is destroyed, the procedure is over and all catheters removed.\nA total of 40 cardiology sites with 30 centres in the U.S./Canada and 10 centres in the Western Europe will enrol a maximum of 350 subjects. Expected total study duration is approximately 36 months, representing 24 months of enrolment and up to 12 months of subject follow-up. \nThe follow-up schedule will be reset for subjects that require a reablation procedure within the phased RF system 6-month post-ablation visits persistent or long-standing persistent atrial fibrillation. \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/0034
Date of REC Opinion
4 Apr 2014
REC opinion
Further Information Favourable Opinion