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 variety of topics in the field of cardiac rhythm management and cardiovascular intervention. In collaboration with international medical experts, we strive to continuously improve the diagnosis and treatment of cardiac and vascular diseases.

The databases below provide an overview of BIOTRONIK’s studies in cardiac rhythm management and cardiovascular intervention, along with related publications and resources.

Clinical Studies

Cardiac Rhythm Management (CRM) Studies

Therapy Field Study Name Publication Title Study Type Number of Patients
Home Monitoring AT-HOME 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
Arrhythmia Monitoring BIO|CONCEPT Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success Observational trial 48
Cardiac Resynchronization BIO|CONTINUE BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication Observational trial 277
Cardiac Resynchronization BIO|WOMEN Clinical Investigation on Differences in the Magnitude of CRT Response in Women Versus MEN Prospective, interventional trial 494
Catheter Ablation CASTLE-AF Catheter Ablation for Atrial Fibrillation with Heart Failure Randomized controlled trial 398
Cardiac Resynchronization CELESTIAL Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads Observational trial 2499
Bradycardia COMPAS A randomized trial of long-term remote monitoring of pacemaker recipients Randomized clinical trial 538
Cardiac Resynchronization EchoCRT Cardiac-Resynchronization Therapy in Heart Failure with a Narrow QRS Complex Randomized controlled trial 1680
Home Monitoring ECOST A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial Randomized controlled trial 433
Tachycardia GALAXY Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads Observational trial 1997
Home Monitoring HoMASQ Long-term patient acceptance of and satisfaction with implanted device remote monitoring Survey 119
Home Monitoring IMPACT Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices  Randomized controlled trial 2718
Home Monitoring IN-TIME Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial Randomized controlled trial 664
Tachycardia, DX KURT Avoiding Inappropriate Therapy of Single-Lead ICDs by Using Atrial-Sensing Electrodes (Investigator-initiated trial) Prospective, single-center, non-randomized trial 212
Tachycardia, DX MATRIX Management and detection of atrial tachyarrhythmia in patients implanted with BIOTRONIK DX systems Observational trial 2054
Tachycardia NORDIC ICD Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial Randomized controlled trial 1077
Bradycardia ProMRI AFFIRM Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions Observational trial 272
Tachycardia Protego Protego DF4 Post Approval Registry Registry 1694
Cardiac Resynchronization QP ExCELs Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs) Observational trial 1868
Cardiac Resynchronization, DX QP ExCELs (CRT-DX) Novel Two-Lead Cardiac Resynchronization Therapy System Provides Equivalent CRT Responses with Less Complications than a Conventional Three-Lead System: Results from the QP ExCELs Lead Registry Observational trial 240
Cardiac Implantable Electronic Devices REPLACE Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures - Results From the REPLACE Registry Registry 1744
Home Monitoring 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 (RM-ALONE)  Randomized controlled trial  445
Tachycardia, DX SENSE Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter defibrillator systems: Results of the SENSE trial Observational trial  450
Bradycardia SIELLO Safety and Performance Study of the Siello S Pacing Lead (SIELLO) Observational trial 1758
Tachycardia, DX THINGS The Role of Atrial Sensing for New-Onset Atrial Arrhythmias Diagnosis and Management in Single-Chamber Implantable Cardioverter Defibrillator Recipients: Results From the THINGS Registry 376
Home Monitoring TRUECOIN Daily Remote Monitoring of Implantable Cardioverter-Defibrillators – Pooled Individual Patient Data from IN-TIME, ECOST, and TRUST Trials Suggest a Mechanism of Clinical Benefit Meta-analysis 2405
Home Monitoring TRUST Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) Trial Randomized controlled trial 1450
Bradycardia BIOSync CLS Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole Randomized controlled trial 445

Vascular Intervention (VI) 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
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
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
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
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
SCAAR Swedish Coronary Angiography and Angioplasty Registry Observational trial > 270000 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
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