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 gestão do ritmo cardíaco e intervenção cardiovascular.

Em colaboração com especialistas médicos internacionais, procuramos 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 a gestão do ritmo cardíaco e intervenção cardiovascular, juntamente com publicações e recursos relacionados.

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65 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

Medical Specialty
Vascular Intervention
Therapy Field
Peripheral Vascular Intervention
Study type
Randomized controlled trial
No. of participants
302
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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

Medical Specialty
Vascular Intervention
Therapy Field
Peripheral Vascular Intervention
Study type
Observational trial
No. of participants
150
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BIOSCIENCE

Medical Specialty
Vascular Intervention
Therapy Field
Coronary Vascular Intervention
Study type
Randomized controlled trial
No. of participants
2,119
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BIOSOLVE-I

First-in man trial with DREAMS (Drug-Eluting Absorbable Magnesium Scaffold)

Medical Specialty
Vascular Intervention
Therapy Field
Coronary Vascular Intervention
Study type
First-in-man trial
No. of participants
46
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BIOSOLVE-II

First in man study of the DREAMS 2nd generation drug-eluting absorbable metal scaffold

Medical Specialty
Vascular Intervention
Therapy Field
Coronary Vascular Intervention
Study type
First-in-man trial
No. of participants
123
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BIOSTEMI

Randomized Clinical Trial comparing the Orsiro Drug Eluting Stent to the Xience Drug Eluting Stent in STEMI patients

Medical Specialty
Vascular Intervention
Therapy Field
Coronary Vascular Intervention
Study type
Randomized controlled trial
No. of participants
1,300
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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. 

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Bradycardia
Study type
Randomized controlled trial
No. of participants
445
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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

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Arrhythmia Monitoring
Study type
Observational trial
No. of participants
31
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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

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Arrhythmia Monitoring
Study type
Observational trial
No. of participants
48
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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)

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Cardiac Resynchronization
Study type
Observational trial
No. of participants
276
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BIO|GUARD-MI

Biomonitoring in Patients with Preserved Left Ventricular Function after Diagnosed Myocardial Infarction

 

Jøns C et al, ACC 2022

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Arrhythmia Monitoring
Study type
Randomized trial
No. of participants
790
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BIO|WOMEN

Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Cardiac Resynchronization
Study type
Prospective, interventional trial
No. of participants
494
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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

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Catheter Ablation
Study type
Randomized controlled trial
No. of participants
398
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COMPAS

A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial)

MABO P ET AL., EUROPEAN HEART JOURNAL, 2012

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Bradycardia
Study type
Randomized clinical trial
No. of participants
538
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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

Medical Specialty
Vascular Intervention
Therapy Field
Peripheral Vascular Intervention
Study type
Observational trial
No. of participants
65
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DELUX

Drug-Releasing Pantera Lux PTCA Balloon Catheter Registry

Medical Specialty
Vascular Intervention
Therapy Field
Coronary Vascular Intervention
Study type
Observational trial
No. of participants
1064
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EchoCRT

Cardiac Resynchronization Therapy in Heart Failure with a Narrow QRS Complex

Ruschitzka et al., The New England Journal of Medicine 2013

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Cardiac Resynchronization
Study type
Randomized controlled trial
No. of participants
1680
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ECOST

Effectiveness and Costs of ICD Follow-up Schedule with Telecardiology

Laurence Guédon-Moreau, European Heart Journal 2013

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Home Monitoring
Study type
Randomized controlled trial
No. of participants
433
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EffPac AV

Evaluating efficacy of pacltaxel-eluting versus standard balloon for stenosis of dysfunctional fistulae and grafts for hemodialysis 

Medical Specialty
Vascular Intervention
Therapy Field
Peripheral Vascular Intervention
Study type
Randomized controlled trial
No. of participants
136
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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

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Home Monitoring
Study type
Survey
No. of participants
119
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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

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Home Monitoring
Study type
Randomized controlled trial
No. of participants
2718
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IN-TIME

Influence of Home Monitoring on the Clinical Status of Heart Failure Patients

Hindricks et al., The Lancet 2014

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Home Monitoring
Study type
Randomized controlled trial
No. of participants
664
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ISAR-DESIRE 4

Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug-Eluting Stent In-Stent Restenosis 4

Medical Specialty
Vascular Intervention
Therapy Field
Coronary Vascular Intervention
Study type
Randomized controlled trial
No. of participants
252
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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

Medical Specialty
Cardiac Rhythm Management
Therapy Field
Tachycardia, DX
Study type
Prospective, single-center, non-randomized trial
No. of participants
212
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