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 NameStudy TopicStudy TypeNumber of PatientsProductsTherapy
CASTLE-AFCatheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillationRandomized controlled trial398 Ablation catheters (any manufacturer), implantable cardioverter defibrillators, cardiac resynchronization therapy devices, BIOTRONIK Home Monitoring Cardiac rhythm management
TRUECOINInsights from the pooled patient-level data from three randomized controlled trials utilizing daily BIOTRONIK Home Monitoring (IN-TIME, ECOST, TRUST)Meta-analysis2405 BIOTRONIK Home Monitoring, implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
EchoCRT Effects of cardiac resynchronization therapy in heart failure with a narrow QRS complexRandomized controlled trial1680Cardiac resynchronization therapy devicesCardiac rhythm management
IMPACT Impact of BIOTRONIK Home Monitoring guided anticoagulation on stroke risk in patients with ICD and CRT-D devicesRandomized controlled trial2718BIOTRONIK Home Monitoring, implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
ECOST Effectiveness and cost of ICD follow-up schedule with telecardiologyRandomized controlled trial433BIOTRONIK Home Monitoring, implantable cardioverter defibrillatorsCardiac rhythm management
MATRIX Management and detection of atrial tachyarrhythmia in patients implanted with BIOTRONIK DX systemsObservational trial2054DX leads, implantable cardioverter defibrillatorsCardiac rhythm management
IN-TIME Influence of BIOTRONIK Home Monitoring on the clinical status of heart failure patientsRandomized controlled trial664BIOTRONIK Home Monitoring, implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
NORDIC ICD Assessment of the need of defibrillation testingRandomized controlled trial1077Implantable cardioverter defibrillatorsCardiac rhythm management
ProMRI AFFIRM/Phase A Clinical safety of the ProMRI pacemaker system when used under specific MRI conditions with scan exclusion zoneProspective, interventional trial272PacemakersCardiac rhythm management
ProMRI Phase B Clinical safety of the ProMRI ICD system when used under specific MRI conditions without scan exclusion zoneProspective, interventional trial170Implantable cardioverter defibrillatorsCardiac rhythm management
Protego Long-term safety and reliability of BIOTRONIK's Protego DF4 leadObservational trial1694Leads, implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
QP ExCELs Safety and efficacy of BIOTRONIK’s quadripolar left ventricular leads (Sentus QP)Prospective, interventional trial1868Leads, cardiac resynchronization therapy devicesCardiac rhythm management
REPLACE Assessment of the complication rate after cardiac device replacement Observational trial1744Implantable cardioverter defibrillators, cardiac resynchronization therapy devicesCardiac rhythm management
SIELLO Safety and effectiveness of the BIOTRONIK Siello S pacing leadObservational trial1758Leads, pacemakersCardiac rhythm management
TRUST Efficacy and safety of automatic remote monitoring for ICD follow-upRandomized controlled trial1450BIOTRONIK Home Monitoring, implantable cardioverter defibrillatorsCardiac rhythm management
GALAXY Long-term evaluation of the Linox family ICD leadsObservational trial1997Leads Implantable cardioverter defibrillatorsCardiac rhythm management
CELESTIAL Long-term safety and reliability of BIOTRONIK’s Corox BP LV leadsObservational trial2499Leads, cardiac resynchronization therapy devicesCardiac rhythm management
BIOWOMENGender differences in the magnitude of CRT response in a heart failure populationProspective, interventional trial494Cardiac resynchronization therapy devicesCardiac rhythm management
BioCONTINUERelevance of a defibrillator back-up after the replacement of the first CRT-DObservational trial277Implantable cardioverter defibrillatorsCardiac rhythm management
BIO-RESORTComparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers populationRandomized controlled trial3530Orsiro Drug-Eluting StentCoronary vascular intervention
BIOSCIENCEOrsiro Sirolimus-eluting stent with biodegradable polymer vs Xience Prima everolimus-eluting stentRandomized controlled trial2100Orsiro Drug-Eluting StentCoronary vascular intervention
SORT-OUT VIIBIOTRONIK Sirolimus-eluting Orsiro stent vs Terumo biolimus-eluting Nobori StentRandomized controlled trial2525Orsiro Drug-Eluting StentCoronary vascular intervention
ORIENTComparison of the angiographic result of the Orsiro stent with Resolute Integrity stentRandomized controlled trial375Orsiro Drug-Eluting StentCoronary vascular intervention
SCAARSwedish Coronary Angiography and Angioplasty RegistryObservational trial> 270000Orsiro Drug-Eluting StentCoronary vascular intervention
BIOFLOW-IFirst-in-man experience with a drug-eluting stent in de novo coronary artery lesions First-in-man trial 30Orsiro Drug-Eluting StentCoronary vascular intervention
BIOFLOW-IIStudy of the Orsiro Drug Eluting Stent SystemRandomized controlled trial440Orsiro Drug-Eluting StentCoronary vascular intervention
BIOFLOW-IIIInvestigating Orsiro drug-eluting coronary stentObservational trial1356Orsiro Drug-Eluting StentCoronary vascular intervention
BIOFLOW-VRandomized Clinical Trial Comparing Orsiro1 Drug-Eluting Stent with Xience2 DESRandomized controlled trial1334Orsiro Drug-Eluting StentCoronary vascular intervention
BIOSOLVE-IFirst-in man trial with DREAMS (Drug-Eluting Absorbable Magnesium Scaffold) First-in-man trial46Magmaris Resorbable Magnesium ScaffoldCoronary vascular intervention
BIOSOLVE-IIFirst in man study of the DREAMS 2nd generation drug-eluting absorbable metal scaffold First-in-man trial123Magmaris Resorbable Magnesium ScaffoldCoronary vascular intervention
DELUX Drug-Releasing Pantera Lux PTCA Balloon Catheter RegistryObservational trial1064Pantera Lux Paclitaxel-Releasing BalloonCoronary vascular intervention
ENERGYRegistry to evaluate the clinical performance of the PRO-Kinetic Energy BMS in a large real-world patient population.Observational trial1016PRO-Kinetic Energy Cobalt Chromium StentCoronary vascular intervention
ISAR-DESIRE 4Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug-Eluting Stent In-Stent Restenosis 4Randomized controlled trial252Pantera Lux Paclitaxel-Releasing Balloon, AngioSculpt Scoring BalloonCoronary vascular intervention
PEBSIA Randomized Trial of Paclitaxel-Eluting Balloon after Bare Metal Stent Implantation versus Bare Metal Stent in ST Elevation Myocardial Infarction (STEMI)Randomized controlled trial223PRO-Kinetic Energy Stent, Pantera Lux Paclitaxel-Releasing BalloonCoronary vascular intervention
PEPPERFirst-In-Human Trial - Paclitaxel-Releasing Balloon in Patients Presenting with In-Stent RestenosisObservational trial81Pantera Lux Paclitaxel-Releasing BalloonCoronary vascular intervention
4EVERPhysician-initiated trial investigating the safety of the full 4F endovascular treatment approach of infra-inguinal arterial stenotic diseaseObservational trial120Astron Pulsar, Pulsar-18 Self-Expanding StentsPeripheral vascular intervention
BERNEvaluate long segment (> 120 mm) complex femoro-popliteal disease with Pulsar stent stratified for Critical Limb Ischaemia vs. Intermittent Claudication1Observational trial31Pulsar-18 Self-Expanding StentPeripheral vascular intervention
BIOFLEX-IProspective, international, multi-center, investigational device exemption trial evaluating BIOTRONIK Astron nitinol self-expanding stent for iliac arteriesObservational trial161Astron Self-Expanding StentPeripheral vascular intervention
BIOLUX P-IClinical 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 arteriesRandomized controlled trial60Passeo-18 Lux Drug-Coated Balloon, Passeo-18 PTA BalloonPeripheral vascular intervention
BIOLUX P-IIFirst-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 arteriesRandomized controlled trial72Passeo-18 Lux Drug-Coated Balloon, Passeo-18 PTA BalloonPeripheral vascular intervention
DEBASTo evaluate the outcome of the implantation of the Pulsar-18 stent followed by Passeo-18 Lux drug-coated balloon in the femoropopliteal arteriesObservational trial65Pulsar-18 Self-Expanding Stent, Passeo-18 Lux Drug-Coated BalloonPeripheral vascular intervention
PEACEPulsar efficacy - An all-comers registry: 12-month results 1Observational trial148Pulsar-18 Self-Expanding StentPeripheral vascular intervention
TASC DTwelve months effectiveness analysis of the Pulsar-18 self-expanding nitinol stent in patients with critical limb ischemia1Observational trial22Pulsar-18 Self-Expanding StentPeripheral vascular intervention
TASC D IIEvaluation of the 4 French Pulsar-18 self-expanding nitinol stent in long femoropopliteal lesions (TASC D II) – 12-month resultsObservational trial36Pulsar-18 Self-Expanding StentPeripheral vascular intervention