RAPID-AF (CF-171)

• Research type

  Research Study

• Full title

  Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF using the RHYTHMFINDER-192

• IRAS ID

  227763

• Contact name

  Richard Schilling

• Contact email

  Richard.Schilling@bartshealth.nhs.uk

• Sponsor organisation

  Biosense Webster, Inc

• Clinicaltrials.gov Identifier

  NCT03064451

• Duration of Study in the UK

  1 years, 3 months, 31 days

• Research summary

  The purpose of this study is to see if the use of CartoFinder (CF) maps created by a diagnostic basket catheter the RhythmFinder-192 (RF-192) and the CartoFinder Algorithm during standard ablation procedure may help to identify repetitive activation patterns and focal impulses and to improve the outcome of treatment of Persistent Atrial Fibrillation (PsAF).

  The CartoFinder Algorithm is a kind of software that analyses and visualizes the electrical activity of the heart in a 4D map for further interpretation by the treating physician. The CF Algorithm is approved for use in Europe.
  The RF-192 basket catheter is a mapping device used to provide a global view of the surface of the heart. This device is investigational. Investigational means that it has not been approved by local government health authorities. This is the first study where this diagnostic basket catheter RhythmFinder-192 will be used in humans.

  The study is prospective, meaning that it follows over time a group of individuals who have a similar medical condition and it will be conducted in 6 to 10 hospitals worldwide, mainly in Europe and Canada (it is multi-center).
  There is only one group of treatment and it will be utilizing the investigational diagnostic basket catheter RhythmFinder-192 (RF-192).

  The study will enroll approximately 40 to 70 subjects. All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation procedure for management of their persistent AF will be the target population for screening.

  Subjects will undergo CARTOFINDER™ guided ablation (CFGA) followed by pulmonary vein isolation (PVI) and will have follow-up visits at 7 days, 3, 6 and 12 months post-procedure.

  Subjects where no CARTOFINDER™ ablation target is identified on the baseline CARTOFINDER™ map using the RHYTHMFINDER™ 192 Catheter, will exit the study after 7 day follow up.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  17/YH/0204

• Date of REC Opinion

  8 Aug 2017

• REC opinion

  Further Information Favourable Opinion