Biotronik announces sponsored clinical trials at ESC 2011


Biotronik announced the list of its sponsored clinical studies on remote monitoring in ICD and CRT-D patients to be presented at the European Society of Cardiology (ESC) Congress to be held in Paris, France, from 27–31 August 2011.

Major highlights include two oral presentations on the ECOST trial (Effectiveness and cost of ICD follow-up schedule with telecardiology) during the Hot Line II and Meet–the-Trialist III sessions. ECOST investigates the safety, effectiveness, and costs of long-term follow-up over 27 months with Biotronik Home Monitoringin ICD patients. In the Hot Line session, principal investigator Salem Kacet will present the results from ECOST, which will then be discussed by Jean-Claude Daubert.

In the Meet–the-Trialist session, participants will have the opportunity to interact directly with Kacet and delve into further details on ECOST. The Meet the Trialist sessions cover five of the best late-breaking trials from the Hot Line sessions.

Additionally, Niraj Varma, principal investigator of TRUST, will present new data from the TRUST trial (Lumax-T/Lumos-T safely reduces routine office device follow-up), which demonstrated the safety and effectiveness of remote follow-up of ICD patients with Biotronik Home Monitoring. This new data will show event detection in high-risk ICD patients with Biotronik Home Monitoringon Sunday, 28 August. On the following day, Varma will present new findings on how well this technology reduces the burden of unnecessary hospital visits.

Furthermore, new findings will be presented from the unique industry-wide REPLACE registry (Implantable cardiac pulse generator replacement), which provides a comprehensive risk quantification of pacemaker and ICD replacement and upgrade. REPLACE principal investigator, Jeanne Poole will show data on the time-course of complications following pacemaker or ICD replacement, and investigator Behzad Pavri will share insights on the likeliness of upgrade to CRT in pacemaker versus ICD patients.

Finally, two more presentations of studies with Biotronik Home Monitoringwill add further substantiation to the significant body of evidence already existing for this advanced technology: Renato Pietro Ricci will show preliminary results from the HomeGuide Registry on the manpower as well as sensitivity and positive predictive value of adverse event detection with Biotronik Home Monitoring. On the other hand, Ermenegildo de Ruvo will share insights on the long-term risk reduction of misdetection or delayed detection of adverse events with Biotronik Home Monitoring in CRT-D patients.

“At Biotronik, we are committed to setting new standards in clinical excellence,” commented Marlou Janssen, global vice president of Marketing and Sales. “Our clinical professionals worldwide collaborate closely with top scientific experts at universities, research institutes, and in the medical community to develop and study highly reliable and innovative products that help physicians save and improve patients’ lives.”

“Our commitment to clinical excellence will be demonstrated this year at the ESC Congress 2011, via a considerable number of significant presentations that examine the clinical experience with a collective total of more than 5,000 patients,” stated Janssen.