Badania kliniczne
Naszym celem jest wspieranie dalszego rozwoju kardiologii, dlatego BIOTRONIK intensywnie wspomaga prowadzenie badań klinicznych. Nasze działanie naukowe obejmują szeroką gamę tematów, w tym: zarządzanie rytmem serca, elektrofizjologię i interwencje sercowo-naczyniowe. Nie ograniczamy się wyłącznie do udowadniania skuteczności i bezpieczeństwa naszych produktów. Jedną z naszych misji jest zajmowanie się lukami w badaniach klinicznych, które są określane przez wiodące instytucje medyczne. Jesteśmy dumni z naszych przełomowych badań i wierzymy, że naszą odpowiedzialnością jest dalsze wspomaganie rozwoju kardiologii. Współpracując z międzynarodowymi ekspertami medycznymi dokładamy starań, aby w sposób ciągły poprawić diagnostykę i leczenie chorób sercowych i naczyniowych. Ten wspólny wysiłek pomaga nam w lepszym określeniu potrzeb naszych pacjentów, którzy będą korzystać z najbardziej optymalnych metod leczenia.
Poniższa baza danych przedstawia przegląd trwających i zakończonych badań arytmicznych i sercowo-naczyniowych prowadzonych przez BIOTRONIK, wraz z powiązanymi publikacjami i zasobami. Nasze działania badawcze uwzględniają:
- Randomizowane badanie kliniczne
- Badanie obserwacyjne
- Badania regulacyjne
Zachęcamy, aby lekarze i pracownicy służby zdrowia zadawali nam pytania, jeżeli chcącą dowiedzieć się więcej na temat najnowszych badań klinicznych w kardiologii.
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 |