MedPath

BIOTRONIK, INC.

🇺🇸United States
Ownership
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Employees
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Market Cap
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Website

Plexa ICD Lead Registry

Terminated
Conditions
Implantable Defibrillator User
First Posted Date
2017-04-06
Last Posted Date
2020-10-14
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
901
Registration Number
NCT03103503
Locations
🇺🇸

Thomas Hospital Research Office, Fairhope, Alabama, United States

🇺🇸

Jeffrey S Goodman MD, Los Angeles, California, United States

🇺🇸

Eisenhower Desert Cardiology, Rancho Mirage, California, United States

and more 25 locations

ProMRI ICD/CRT-D Post Approval Study

Completed
Conditions
Tachyarrhythmia
First Posted Date
2016-10-14
Last Posted Date
2019-10-22
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
24249
Registration Number
NCT02933619

BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment

Completed
Conditions
Insertable Cardiac Monitor
First Posted Date
2016-04-29
Last Posted Date
2018-10-26
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
77
Registration Number
NCT02756338

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

Not Applicable
Completed
Conditions
Myocardial Ischemia
Ischemic Heart Disease
Angina Pectoris
Coronary Artery Disease
Atherosclerosis, Coronary
Acute Coronary Syndrome
Interventions
Device: Orsiro DES
Device: Xience DES
First Posted Date
2015-03-17
Last Posted Date
2022-08-03
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
1334
Registration Number
NCT02389946

Protego DF4 Post Approval Registry

Terminated
Conditions
Implantable Defibrillator User
First Posted Date
2014-09-18
Last Posted Date
2020-06-22
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
1694
Registration Number
NCT02243696

ProMRI Study of the Iforia ICD System (Phase C)

Completed
Conditions
Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
Interventions
Device: Patients with a ProMRI ICD System
Other: Magnetic Resonance Imaging (MRI) scan
First Posted Date
2014-03-26
Last Posted Date
2016-02-29
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
154
Registration Number
NCT02096692

ProMRI Study of the Entovis Pacemaker System (Phase B)

Completed
Conditions
Magnetic Resonance Imaging (MRI); Cardiac Pacing
Interventions
Device: Patients with a ProMRI Pacemaker System
Other: Magnetic Resonance Imaging (MRI) scan
First Posted Date
2013-12-12
Last Posted Date
2015-11-25
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
221
Registration Number
NCT02009696

Safety and Performance Study of the Siello S Pacing Lead

Terminated
Conditions
Safety and Effectiveness of the Siello S Lead
Interventions
Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.
First Posted Date
2013-02-13
Last Posted Date
2020-06-01
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
1758
Registration Number
NCT01791127

ProMRI Study of the Entovis Pacemaker System

Completed
Conditions
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Interventions
Device: Patients with a ProMRI Pacemaker System
Other: Magnetic Resonance Imaging (MRI) scan
First Posted Date
2013-01-04
Last Posted Date
2017-02-09
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
229
Registration Number
NCT01761162
Locations
🇺🇸

John Muir Medical Center, Concord, California, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of Massachusetts Medical School, Worcester, Massachusetts, United States

and more 14 locations

BIOHELIX-I Bare Metal Stent Study

Phase 2
Completed
Conditions
Coronary Arteries Disease
Interventions
Device: PRO-Kinetic Energy Stent
First Posted Date
2012-06-06
Last Posted Date
2018-09-28
Lead Sponsor
Biotronik, Inc.
Target Recruit Count
329
Registration Number
NCT01612767
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