ZERO AF

• Research type

  Research Study

• Full title

  Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation: ZERO AF

• IRAS ID

  152213

• Contact name

  Derek T. Connelly

• Contact email

  Derek.Connelly@nhs.net

• Sponsor organisation

  Boston Scientific

• Research summary

  ZERO-AF is a prospective, 1:1 randomised, single-blinded, multi-centre, controlled global investigation.

  The objective of this study is to establish the safety and effectiveness of the Blazer OI Catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF).

  In order to assess the effect of pulmonary vein isolation (PVI) using RF ablation with openirrigated catheters on the potential narrowing of the pulmonary vein diameter, a subset of subjects will be randomized to participate in a PV Imaging Sub-Study.

  Subjects included in the ZERO AF study should be selected from the Investigator’s general patient population indicated for catheter ablation of PAF.

  The devices to be used in the ZERO AF Clinical study are identical in specification, functionality and performance to those approved for Conformité Européene (CE) Marking with the exception of the universal part numbers (UPNs). Specific UPNs have been designated for the ZERO AF study for traceability purposes.

• REC name

  West of Scotland REC 1

• REC reference

  14/WS/1007

• Date of REC Opinion

  30 Jul 2014

• REC opinion

  Further Information Favourable Opinion