GOLD AF Registry

• Research type

  Research Study

• Full title

  GOLD AF Registry: A post-market release, multi-national, multi-centre, prospective observational study in patients with atrial fibrillation treated with the Medtronic Phased RFA system.

• IRAS ID

  172618

• Contact name

  Stephen Furniss

• Contact email

  sfurniss@nhs.net

• Sponsor organisation

  Medtronic International Trading Sárl

• Clinicaltrials.gov Identifier

  NCT02433613, Clintrials.gov

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The GOLD AF (atrial fibrillation) Registry will assess treatment by PVAC GOLD ablation of patients with paroxysmal (occasional) or persistent Atrial Fibrillation (AF), lone AF or AF with underlying disease, and provide data on acute and mid-term success rates, as well as other procedural details and patient characteristics. It will enroll up to 1,000 patients at 50 sites in 11 countries: Belgium, France, Germany, Greece, Israel, Italy, The Netherlands, Poland, Spain, Switzerland and the United Kingdom. Patients will be observed for 12 months following a Phased Radio Frequency Ablation (RFA) procedure. The phased radiofrequency ablation system is currently approved for use in Asia, Australia, Canada, Europe and South Africa.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  16/SC/0475

• Date of REC Opinion

  13 Sep 2016

• REC opinion

  Further Information Favourable Opinion