Estudos clínicos
Comprometida em apoiar novos desenvolvimentos em cardiologia, a BIOTRONIK está profundamente envolvida na condução de ensaios clínicos.
As nossas atividades científicas abrangem uma variedade de tópicos na área de gerenciamento do ritmo cardíaco e intervenção cardiovascular.
Em colaboração com especialistas médicos internacionais, buscamos melhorar, continuamente, o diagnóstico e o tratamento de doenças cardíacas e vasculares.
Os bancos de dados abaixo fornecem uma visão geral dos estudos da BIOTRONIK sobre gerenciamento do ritmo cardíaco e intervenção cardiovascular, juntamente com publicações e recursos relacionados.
Filter Clinical Studies
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
Watanabe E ET AL., CIRCEP 2020 May;13(5):e007734
doi: 10.1161/CIRCEP.119.007734
BIOMONITOR III Pooled Analysis
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
Deneke T et al., Heart Rhythm O2, 2022
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
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
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
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
MATRIX¹
Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole
QP ExCELs
Sentus QP - Extended CRT Evaluation with Quadripolar Left Ventricular Leads
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
Shaik N et al., Journal of Cardiovascular Electrophysiology, May 2020.
doi: 10.1111/jce.14552
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
GARCIA FJ ET AL., EUROPEAN HEART JOURNAL 2019
SELENE HF
Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations (SELENE HF)
D’Onofrio A et al. Europace 2021
doi: 10.1093/europace/euab170.
SENSE
Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter defibrillator systems: Results of the SENSE trial
THOMAS G ET AL., JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 2019
doi: 10.1111/JCE.14081
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
BIFFI M ET AL., JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 2020
doi: 10.1111/jce.14396
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
Hindricks et al., European Heart Journal 2017