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.
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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 |
| Arrhythmia Monitoring | BIO|MASTER.BIOMONITOR III, BIO|STREAM.ICM | New Generation Miniaturized Insertable Cardiac Monitor with a Long Sensing Vector: Insertion Procedure, Sensing Performance, and Home Monitoring Transmission Success in a Real-World Population | Pooled analysis | 653 |
| Arrhythmia Monitoring | BioVAD | Accuracy of atrial fibrillation detection by an insertable cardiac monitor in patients undergoing catheter ablation: Results of the BioVAD study | Observational trial | 31 |
| 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 |
| Arrhythmia Monitoring | BIO|GUARD-MI | The impact of arrhythmia monitoring on clinical outcome in post-myocardial infarction patients | Randomized trial | 790 |
| 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 |
| Bradycardia | ProMRI (Phase B) | Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions | 245 | |
| Bradycardia | ProMRI (Phase C) | Clinical Safety of the ProMRI ICD System when Used Under Specific MRI Conditions without Scan Exclusion Zone | 170 | |
| 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 |
| Heart Failure | Selene HF | Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations | Observational trial | 918 |
| 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 |
| Bradycardia | Zingarini | Permanent His bundle pacing using a new tridimensional delivery sheath and a standard active fixation pacing lead: The telescopic technique | Single-center study | 17 |
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 |