Iperia/Sentus QP

• Research type

  Research Study

• Full title

  Iperia Family / Sentus QP Master Study

• IRAS ID

  155491

• Contact name

  Craig Barr

• Contact email

  craigbarr@nhs.net

• Sponsor organisation

  Biotronik SE & Co. KG

• Clinicaltrials.gov Identifier

  NCT02181686

• Research summary

  Heart failure (HF) is a major public health issue. Cardiac resynchronization therapy (CRT), combined with a standard medical treatment, has been shown as a beneficial therapy for some patients suffering from HF. Despite many improvements in techniques and equipment for this device therapy, phrenic nerve stimulation (PNS) or elevated pacing thresholds are still frequent issues. The combination of the new BIOTRONIK left ventricular lead family Sentus QP, containing 4 separate electrodes, with the corresponding Iperia family Implantable Cardiac Defibrillator (ICD) devices, provide additional pacing options to optimize CRT.

  PNS occurs when a device's electrical output inadvertently activates the diaphragm
  muscle and causes muscle twitching, hiccough, or shortness of breath. With unipolar and bipolar left ventricular leads, PNS may require surgery to reposition the lead or disable the CRT. With four electrodes on the left ventricular (LV) lead and 12 programmable pacing configurations, available with the Sentus QP/Iperia ICD System, an occurrence of PNS or increased LV pacing thresholds may be treated by non-invasive optimization of CRT delivery. The risk of surgical revision during follow up is reduced. Apart from limiting risks of CRT, quadripolar (QP) leads with multiple additional pacing vectors can also increase cardiac output compared to conventional bipolar LV leads and thus enhance the overall benefit of CRT.

  The Iperia ICD family / Sentus QP quadripolar lead study aims to gather safety and
  effectiveness data on BIOTRONIK Sentus QP leads and the Iperia family ICDs. It focuses on the HF-T QP device system with the extended LV pacing options, but patient subgroups with single and dual chamber ICDs (VR-T, DR-T) will also be included to cover the whole Iperia ICD family. The study is an open, prospective, multi-center clinical study. Patient study participation will last 3 months from enrolment.

• REC name

  West Midlands - South Birmingham Research Ethics Committee

• REC reference

  14/WM/1076

• Date of REC Opinion

  4 Sep 2014

• REC opinion

  Further Information Favourable Opinion