Klinische Studien
Angetrieben durch das Ziel, die Weiterentwicklung der Kardiologie voranzutreiben, führt BIOTRONIK zahlreiche klinische Studien durch.
Unsere wissenschaftlichen Aktivitäten umfassen ein weites Feld verschiedener Themengebiete wie Herzrhythmusmanagement, Elektrophysiologie und kardiovaskuläre Intervention. Dabei beschränken wir uns nicht auf den Nachweis der Sicherheit und Effizienz unserer Produkte, sondern arbeiten an den von führenden medizinischen Institutionen identifizierten Lücken in der Forschung. Bestätigt durch unsere Landmark-Studien sehen wir uns in der Verantwortung, durch aktive Beteiligung Fortschritte auf dem Gebiet der Kardiologie zu erzielen.
In Zusammenarbeit mit internationalen medizinischen Experten engagieren wir uns für die Weiterentwicklung der Diagnostik und Behandlung von kardiovaskulären Erkrankungen. Diese Kooperationen helfen uns, die Bedürfnisse der Patienten zu verstehen und ihnen die bestmögliche Behandlung zukommen zu lassen.
Die Auflistung gibt einen Überblick über laufende und abgeschlossene klinische Studien zu Herzrhythmusstörungen und kardiovaskulärer Erkrankungen und Behandlungen und bietet Verweise zu Publikationen oder anderen Quellen.
- randomisierte klinische Studien
- Beobachtungsstudien
- Zulassungsstudien
Für Anfragen von medizinischen Fachkräften, die mehr über laufende klinische Studien im Bereich Kardiologie erfahren möchten, stehen wir gerne zur Verfügung.
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| 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 |