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 Name Study Topic Study Type Number of Patients Products Therapy
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
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
BM III CONCEPT BIOMONITOR III insertion procedure, sensing quality and Home Monitoring transmission success Observational trial 48 BIOMONITOR III 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
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
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
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
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
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
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
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
CELESTIAL Long-term safety and reliability of BIOTRONIK’s Corox BP LV leads Observational trial 2499 Leads, cardiac resynchronization therapy devices Cardiac rhythm management
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
DELUX Drug-Releasing Pantera Lux PTCA Balloon Catheter Registry Observational trial 1064 Pantera Lux Paclitaxel-Releasing Balloon Coronary vascular intervention
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
ECOST Effectiveness and cost of ICD follow-up schedule with telecardiology Randomized controlled trial 433 BIOTRONIK Home Monitoring, implantable cardioverter defibrillators Cardiac rhythm management
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
GALAXY Long-term evaluation of the Linox family ICD leads Observational trial 1997 Leads Implantable cardioverter defibrillators Cardiac rhythm management
HoMASQ Patient’s acceptance of and satisfaction with remote implantable device monitoring Survey 119 BIOTRONIK Home Monitoring, pacemakers, implantable cardioverter defibrillators 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
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
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
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
NORDIC ICD Assessment of the need of defibrillation testing Randomized controlled trial 1077 Implantable cardioverter defibrillators Cardiac rhythm management
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
PEACE Pulsar efficacy - An all-comers registry: 12-month results 1 Observational trial 148 Pulsar-18 Self-Expanding Stent Peripheral 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
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
QP ExCELs (CRT-DX) Comparison of complication rates and CRT response in two-lead CRT-DX vs. in standard CRT-D system Registry 240 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
SCAAR Swedish Coronary Angiography and Angioplasty Registry Observational trial > 270000 Orsiro Drug-Eluting Stent Coronary vascular intervention
SIELLO Safety and effectiveness of the BIOTRONIK Siello S pacing lead Observational trial 1758 Leads, pacemakers Cardiac rhythm management
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
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
THINGS Improvements of AT/AF diagnosis and management with a single-lead ICD with an atrial dipole (ICD DX) Registry 376 Implantable cardioverter defibrillators, Biotronik DX system 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
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
COMPAS A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial)   538    
SENSE Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter defibrillator systems: Results of the SENSE trial   450    
RM-ALONE Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial Randomized controlled trial 445 BIOTRONIK pacemakers and ICDs, BIOTRONIK Home Monitoring Cardiac rhythm management
AT HOME STUDY Remote Management of Pacemaker Patients with Biennial In-clinic evaluation: Continuous
Home Monitoring in the Japanese at Home Study. A Randomized Clinical Trial
Randomized controlled trial 1274 Evia pacemakers, BIOTRONIK Home Monitoring Cardiac rhythm management
BIOSync CLS Assess the efficacy of cardiac pacing with CLS in preventing syncopal recurrences in patients with severe recurrent reflex syncope and tilt induced asystole

Randomized controlled trial 127 Pacemakers with CLS Cardiac rhythm management