Klinische Studien
BIOTRONIK ist bestrebt, weitere Entwicklungen in der Kardiologie zu unterstützen und hat sich intensiv an der Durchführung klinischer Studien beteiligt. Unsere wissenschaftlichen Aktivitäten umfassen eine Vielzahl von Themen auf dem Gebiet des Herzrhythmusmanagements und der kardiovaskulären Intervention. In Zusammenarbeit mit internationalen medizinischen Experten sind wir bestrebt, die Diagnostik und Behandlung von Herz- und Gefäßerkrankungen kontinuierlich zu verbessern.
Die nachstehenden Datenbanken bieten einen Überblick über die Studien von BIOTRONIK im Bereich Herzrhythmusmanagement und kardiovaskuläre Intervention sowie über damit zusammenhängende Veröffentlichungen und Quellen.
Filter Clinical Studies
BIOPACT RCT
Noninferiority trial comparing the safety and efficacy of the Passeo-18 Lux DCB against the In.Pact Admiral DCB in femoropopliteal lesions
BIOREACT
Evaluating the utility of procedural diagnostics in deciding when and where to place a stent, as well as the safety and efficacy of Passeo-18 Lux DCB associated to Pulsar-18 BMS placement
BIOSCIENCE
BIOSOLVE-I
First-in man trial with DREAMS (Drug-Eluting Absorbable Magnesium Scaffold)
BIOSOLVE-II
First in man study of the DREAMS 2nd generation drug-eluting absorbable metal scaffold
BIOSTEMI
Randomized Clinical Trial comparing the Orsiro Drug Eluting Stent to the Xience Drug Eluting Stent in STEMI patients
BIOSync CLS
Cardiac Pacing in Severe Recurrent Reflex Syncope and Tilt-Induced Asystole
Brignole M, Russo V, Arabia F, Oliveira M, Pedrote A, Aerts A, Rapacciuolo A, Boveda S, Deharo JC, Maglia G, Nigro G, Giacopelli D, Gargaro A, Tomaino M; BioSync CLS trial Investigators. Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. Eur Heart J. 2021 Feb 1;42(5):508-516.
BioVAD
Accuracy of atrial fibrillation detection by an insertable cardiac monitor in patients undergoing catheter ablation: Results of the BioVAD study
Assaf A et al., Ann Noninvasive Electrocardiol., 2022
BIO|CONCEPT.BIOMONITOR III
Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success
MARIANI J ET AL.,JOURNAL OF ELECTROCARDIOLOGY 2020
BIO|CONTINUE
BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
Gras, D., Clémenty, N., Ploux, S. et al. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol (2022)
BIO|GUARD-MI
Biomonitoring in Patients with Preserved Left Ventricular Function after Diagnosed Myocardial Infarction
Jøns C et al, ACC 2022
BIO|WOMEN
Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN
CASTLE-AF
Catheter Ablation Versus Standard Conventional Treatment in Patients with Left Ventricular Dysfunction and Atrial Fibrillation
Marrouche NF, Brachmann J et al., New England Journal of Medicine 2018
COMPAS
A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial)
MABO P ET AL., EUROPEAN HEART JOURNAL, 2012
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
DELUX
Drug-Releasing Pantera Lux PTCA Balloon Catheter Registry
EchoCRT
Cardiac Resynchronization Therapy in Heart Failure with a Narrow QRS Complex
Ruschitzka et al., The New England Journal of Medicine 2013
ECOST
Effectiveness and Costs of ICD Follow-up Schedule with Telecardiology
Laurence Guédon-Moreau, European Heart Journal 2013
EffPac AV
Evaluating efficacy of pacltaxel-eluting versus standard balloon for stenosis of dysfunctional fistulae and grafts for hemodialysis
HoMASQ (Home Monitoring Acceptance and Satisfaction Questionnaire)
Long-term patient acceptance of and satisfaction with implanted device remote monitoring
Ricci PR ET AL., Europace (2010) 12, 674–679
IMPACT
The IMPACT of BIOTRONIK Home Monitoring Guided Anticoagulation on Stroke Risk in Patients with ICD and CRT-D Devices
Martin et al., European Heart Journal 2015
IN-TIME
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
Hindricks et al., The Lancet 2014
ISAR-DESIRE 4
Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug-Eluting Stent In-Stent Restenosis 4
Kurt et al. (2018)
Avoiding inappropriate therapy of single‐lead implantable cardioverter‐defibrillator by using atrial‐sensing electrodes
Kurt M et al., Journal of Cardiovascular Electrophysiology, September 2018. doi: 10.1111/jce.13736
Investigator-initiated trial, not funded by BIOTRONIK