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Clinical Studies

Committed to supporting further developments in cardiology, BIOTRONIK has been deeply involved in conducting clinical trials. Our scientific activities encompass a variety of topics in the field of cardiac rhythm management and cardiovascular intervention. In collaboration with international medical experts, we strive to continuously improve the diagnosis and treatment of cardiac and vascular diseases.

The databases below provide an overview of BIOTRONIK’s studies in cardiac rhythm management and cardiovascular intervention, along with related publications and resources.

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68 Clinical Studies

MATRIX¹

Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole

 

ORIENT

Comparison of the angiographic result of the Orsiro stent with Resolute Integrity stent

PEACE

Pulsar efficacy - An all-comers registry: 12-month results

PEPPER

First-In-Human Trial - Paclitaxel-Releasing Balloon in Patients Presenting with In-Stent Restenosis

Protego

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

REPLACE

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

SCAAR

Swedish Coronary Angiography and Angioplasty Registry

SCAAR

Long term outcome after treatment of de novo coronary artery lesions using three different drug coated balloons

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

SIELLO

Safety and Performance Study of the Siello S Pacing Lead

SORT-OUT VII

BIOTRONIK Sirolimus-eluting Orsiro stent vs Terumo biolimus-eluting Nobori Stent

TASC D

Twelve months effectiveness analysis of the Pulsar-18 self-expanding nitinol stent in patients with critical limb ischemia

TASC D II

Evaluation of the 4 French Pulsar-18 self-expanding nitinol stent in long femoropopliteal lesions (TASC D II) – 12-month results

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

TRUST

Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up

Varma, Circulation 2012