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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| Study Name | Study Topic | Study Type | Number of Patients | Products | Therapy |
|---|---|---|---|---|---|
| CASTLE-AF | Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation | Randomized controlled trial | 398 | Ablation catheters (any manufacturer), implantable cardioverter defibrillators, cardiac resynchronization therapy devices, BIOTRONIK Home Monitoring | Cardiac rhythm management |
| TRUECOIN | Insights from the pooled patient-level data from three randomized controlled trials utilizing daily BIOTRONIK Home Monitoring (IN-TIME, ECOST, TRUST) | Meta-analysis | 2405 | BIOTRONIK Home Monitoring, implantable cardioverter defibrillators, cardiac resynchronization therapy devices | Cardiac rhythm management |
| 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 |
| ECOST | Effectiveness and cost of ICD follow-up schedule with telecardiology | Randomized controlled trial | 433 | BIOTRONIK Home Monitoring, implantable cardioverter defibrillators | Cardiac rhythm management |
| MATRIX | Management and detection of atrial tachyarrhythmia in patients implanted with BIOTRONIK DX systems | Observational trial | 2054 | DX leads, implantable cardioverter defibrillators | Cardiac rhythm management |
| IN-TIME | Influence of BIOTRONIK Home Monitoring on the clinical status of heart failure patients | Randomized controlled trial | 664 | BIOTRONIK Home Monitoring, implantable cardioverter defibrillators, cardiac resynchronization therapy devices | Cardiac rhythm management |
| NORDIC ICD | Assessment of the need of defibrillation testing | Randomized controlled trial | 1077 | Implantable cardioverter defibrillators | 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 |
| BIOWOMEN | Gender differences in the magnitude of CRT response in a heart failure population | Prospective, interventional trial | 494 | Cardiac resynchronization therapy devices | Cardiac rhythm management |
| BioCONTINUE | Relevance of a defibrillator back-up after the replacement of the first CRT-D | Observational trial | 277 | Implantable cardioverter defibrillators | Cardiac rhythm management |
| BIO-RESORT | Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population | Randomized controlled trial | 3530 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| BIOSCIENCE | Orsiro Sirolimus-eluting stent with biodegradable polymer vs Xience Prima everolimus-eluting stent | Randomized controlled trial | 2100 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| SORT-OUT VII | BIOTRONIK Sirolimus-eluting Orsiro stent vs Terumo biolimus-eluting Nobori Stent | Randomized controlled trial | 2525 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| ORIENT | Comparison of the angiographic result of the Orsiro stent with Resolute Integrity stent | Randomized controlled trial | 375 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| SCAAR | Swedish Coronary Angiography and Angioplasty Registry | Observational trial | > 270000 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| BIOFLOW-I | First-in-man experience with a drug-eluting stent in de novo coronary artery lesions | First-in-man trial | 30 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| BIOFLOW-II | Study of the Orsiro Drug Eluting Stent System | Randomized controlled trial | 440 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| BIOFLOW-III | Investigating Orsiro drug-eluting coronary stent | Observational trial | 1356 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| BIOFLOW-V | Randomized Clinical Trial Comparing Orsiro1 Drug-Eluting Stent with Xience2 DES | Randomized controlled trial | 1334 | Orsiro Drug-Eluting Stent | Coronary vascular intervention |
| BIOSOLVE-I | First-in man trial with DREAMS (Drug-Eluting Absorbable Magnesium Scaffold) | First-in-man trial | 46 | Magmaris Resorbable Magnesium Scaffold | Coronary vascular intervention |
| BIOSOLVE-II | First in man study of the DREAMS 2nd generation drug-eluting absorbable metal scaffold | First-in-man trial | 123 | Magmaris Resorbable Magnesium Scaffold | Coronary vascular intervention |
| DELUX | Drug-Releasing Pantera Lux PTCA Balloon Catheter Registry | Observational trial | 1064 | Pantera Lux Paclitaxel-Releasing Balloon | Coronary vascular intervention |
| ENERGY | Registry to evaluate the clinical performance of the PRO-Kinetic Energy BMS in a large real-world patient population. | Observational trial | 1016 | PRO-Kinetic Energy Cobalt Chromium Stent | Coronary vascular intervention |
| ISAR-DESIRE 4 | Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug-Eluting Stent In-Stent Restenosis 4 | Randomized controlled trial | 252 | Pantera Lux Paclitaxel-Releasing Balloon, AngioSculpt Scoring Balloon | Coronary vascular intervention |
| PEBSI | A Randomized Trial of Paclitaxel-Eluting Balloon after Bare Metal Stent Implantation versus Bare Metal Stent in ST Elevation Myocardial Infarction (STEMI) | Randomized controlled trial | 223 | PRO-Kinetic Energy Stent, Pantera Lux Paclitaxel-Releasing Balloon | Coronary vascular intervention |
| PEPPER | First-In-Human Trial - Paclitaxel-Releasing Balloon in Patients Presenting with In-Stent Restenosis | Observational trial | 81 | Pantera Lux Paclitaxel-Releasing Balloon | Coronary vascular intervention |
| 4EVER | Physician-initiated trial investigating the safety of the full 4F endovascular treatment approach of infra-inguinal arterial stenotic disease | Observational trial | 120 | Astron Pulsar, Pulsar-18 Self-Expanding Stents | Peripheral vascular intervention |
| BERN | Evaluate long segment (> 120 mm) complex femoro-popliteal disease with Pulsar stent stratified for Critical Limb Ischaemia vs. Intermittent Claudication1 | Observational trial | 31 | Pulsar-18 Self-Expanding Stent | Peripheral vascular intervention |
| BIOFLEX-I | Prospective, international, multi-center, investigational device exemption trial evaluating BIOTRONIK Astron nitinol self-expanding stent for iliac arteries | Observational trial | 161 | Astron Self-Expanding Stent | Peripheral vascular intervention |
| BIOLUX P-I | Clinical trial to assess the safety and performance of the coated Passeo-18 Lux paclitaxel-releasing PTA balloon catheter versus the uncoated Passeo-18 balloon catheter for treatment of stenosis of the femoropopliteal arteries | Randomized controlled trial | 60 | Passeo-18 Lux Drug-Coated Balloon, Passeo-18 PTA Balloon | Peripheral vascular intervention |
| BIOLUX P-II | First-in-human study to assess the safety and performance of the Passeo-18 Lux drug-coated balloon vs. the uncoated Passeo-18 balloon catheter in patients with stenosis and occlusion of the infrapopliteal arteries | Randomized controlled trial | 72 | Passeo-18 Lux Drug-Coated Balloon, Passeo-18 PTA Balloon | Peripheral vascular intervention |
| DEBAS | To evaluate the outcome of the implantation of the Pulsar-18 stent followed by Passeo-18 Lux drug-coated balloon in the femoropopliteal arteries | Observational trial | 65 | Pulsar-18 Self-Expanding Stent, Passeo-18 Lux Drug-Coated Balloon | Peripheral vascular intervention |
| PEACE | Pulsar efficacy - An all-comers registry: 12-month results 1 | Observational trial | 148 | Pulsar-18 Self-Expanding Stent | Peripheral vascular intervention |
| TASC D | Twelve months effectiveness analysis of the Pulsar-18 self-expanding nitinol stent in patients with critical limb ischemia1 | Observational trial | 22 | Pulsar-18 Self-Expanding Stent | Peripheral vascular intervention |
| TASC D II | Evaluation of the 4 French Pulsar-18 self-expanding nitinol stent in long femoropopliteal lesions (TASC D II) – 12-month results | Observational trial | 36 | Pulsar-18 Self-Expanding Stent | Peripheral vascular intervention |