Gen2 Hardware Submission for CL-SVT-002

• Research type

  Research Study

• Full title

  Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia (DDRAMATIC-SVT)

• IRAS ID

  162403

• Contact name

  John Schultz

• Contact email

  john.schultz@acutusmedical.com

• Sponsor organisation

  Acutus Medical

• Clinicaltrials.gov Identifier

  NCT01875614

• Clinicaltrials.gov Identifier

  2013-002469-20, EudraCT

• Research summary

  This study will investigate the feasibility of using the Acutus Medical System for diagnosing or "mapping" of rapid and/or irregular heartbeats (together called arrhythmias) in the upper chambers of the heart. The new System will be used to collect data during routine procedures for treating these arrhythmias. The data collected will be used to create maps of the heart but no therapy will be guided by the new System or any maps generated by the System.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  14/EE/1144

• Date of REC Opinion

  24 Oct 2014

• REC opinion

  Further Information Favourable Opinion