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