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.
| Study Name | Study Topic | Study Type | Number of Patients | Products | Therapy |
|---|---|---|---|---|---|
| EchoCRT | Effects of cardiac resynchronization therapy in heart failure with a narrow QRS complex | Randomized controlled trial | 1680 | Cardiac resynchronization therapy devices | Cardiac rhythm management |
| IMPACT | Impact of BIOTRONIK Home Monitoring guided anticoagulation on stroke risk in patients with ICD and CRT-D devices | Randomized controlled trial | 2718 | BIOTRONIK Home Monitoring, implantable cardioverter defibrillators, cardiac resynchronization therapy devices | Cardiac rhythm management |
| ProMRI AFFIRM/Phase A | Clinical safety of the ProMRI pacemaker system when used under specific MRI conditions with scan exclusion zone | Prospective, interventional trial | 272 | Pacemakers | Cardiac rhythm management |
| ProMRI Phase B | Clinical safety of the ProMRI ICD system when used under specific MRI conditions without scan exclusion zone | Prospective, interventional trial | 170 | Implantable cardioverter defibrillators | Cardiac rhythm management |
| Protego | Long-term safety and reliability of BIOTRONIK's Protego DF4 lead | Observational trial | 1694 | Leads, implantable cardioverter defibrillators, cardiac resynchronization therapy devices | Cardiac rhythm management |
| QP ExCELs | Safety and efficacy of BIOTRONIK’s quadripolar left ventricular leads (Sentus QP) | Prospective, interventional trial | 1868 | Leads, cardiac resynchronization therapy devices | Cardiac rhythm management |
| REPLACE | Assessment of the complication rate after cardiac device replacement | Observational trial | 1744 | Implantable cardioverter defibrillators, cardiac resynchronization therapy devices | Cardiac rhythm management |
| SIELLO | Safety and effectiveness of the BIOTRONIK Siello S pacing lead | Observational trial | 1758 | Leads, pacemakers | Cardiac rhythm management |
| TRUST | Efficacy and safety of automatic remote monitoring for ICD follow-up | Randomized controlled trial | 1450 | BIOTRONIK Home Monitoring, implantable cardioverter defibrillators | Cardiac rhythm management |
| GALAXY | Long-term evaluation of the Linox family ICD leads | Observational trial | 1997 | Leads Implantable cardioverter defibrillators | Cardiac rhythm management |
| CELESTIAL | Long-term safety and reliability of BIOTRONIK’s Corox BP LV leads | Observational trial | 2499 | Leads, cardiac resynchronization therapy devices | Cardiac rhythm management |