Clinical Trials

Clinical Trials

Committed to supporting further developments in cardiology, BIOTRONIK has been deeply involved in conducting clinical trials. Our scientific activities encompass a wide variety of topics, including: cardiac rhythm management, electrophysiology and cardiovascular intervention. We do not limit ourselves solely to proving the safety and efficacy of our products. One of our missions is to address gaps in clinical research identified by leading medical institutions. Proud of our landmark trials, we believe it is our responsibility to foster progress in the field of cardiology. In collaboration with international medical experts, we strive to continuously improve the diagnosis and treatment of cardiac and vascular diseases. This mutual effort helps us to better identify the needs of our patients who benefit from the most optimal treatments.

The database below provides an overview of BIOTRONIK’s ongoing and completed cardiac arrhythmia trials and cardiovascular trials, along with related publications and resources. Our research activities include:

  • randomized clinical trials
  • observational trials
  • regulatory trials

We welcome inquiries from physicians and healthcare professionals eager to find out more about recent clinical trials in cardiology.

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Clinical Studies

Study NameStudy TopicStudy TypeNumber of PatientsProductsTherapy
EchoCRT Effects of cardiac resynchronization therapy in heart failure with a narrow QRS complexRandomized controlled trial1680Cardiac resynchronization therapy devicesCardiac rhythm management
IMPACT Impact of BIOTRONIK Home Monitoring guided anticoagulation on stroke risk in patients with ICD and CRT-D devicesRandomized controlled trial2718BIOTRONIK Home Monitoring, implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
ProMRI AFFIRM/Phase A Clinical safety of the ProMRI pacemaker system when used under specific MRI conditions with scan exclusion zoneProspective, interventional trial272PacemakersCardiac rhythm management
ProMRI Phase B Clinical safety of the ProMRI ICD system when used under specific MRI conditions without scan exclusion zoneProspective, interventional trial170Implantable cardioverter defibrillatorsCardiac rhythm management
Protego Long-term safety and reliability of BIOTRONIK's Protego DF4 leadObservational trial1694Leads, implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
QP ExCELs Safety and efficacy of BIOTRONIK’s quadripolar left ventricular leads (Sentus QP)Prospective, interventional trial1868Leads, cardiac resynchronization therapy devicesCardiac rhythm management
REPLACE Assessment of the complication rate after cardiac device replacement Observational trial1744Implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
SIELLO Safety and effectiveness of the BIOTRONIK Siello S pacing leadObservational trial1758Leads, pacemakersCardiac rhythm management
TRUST Efficacy and safety of automatic remote monitoring for ICD follow-upRandomized controlled trial1450BIOTRONIK Home Monitoring, implantable cardioverter defibrillatorsCardiac rhythm management
GALAXY Long-term evaluation of the Linox family ICD leadsObservational trial1997Leads Implantable cardioverter defibrillatorsCardiac rhythm management
CELESTIAL Long-term safety and reliability of BIOTRONIK’s Corox BP LV leadsObservational trial2499Leads, cardiac resynchronization therapy devicesCardiac rhythm management