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Active (not recruiting) NCT02536118

Micra Transcatheter Pacing System Post-Approval Registry

Conditions: Bradycardia

Sponsor: Medtronic

trial.available_in: БГ
Overview
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release. The Micra Registry is conducted within Medtronic's Product Surveillance Registry.
Description
The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry\*. Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years. \*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.
Who can participate
Inclusion Criteria: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure Exclusion Criteria: * Patient who is, or is expected to be inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Locations 21
Belgium (1)
Brussels
Canada (1)
Kingston , Ontario
Czech Republic (1)
Prague
Denmark (1)
Aarhus
France (1)
Annecy
Greece (1)
Athens
Hungary (1)
Budapest
Iceland (1)
Reykjavik
Israel (1)
Ashkelon
Italy (1)
Bari
Japan (1)
Mitaka-shi , Tokyo
Kuwait (1)
Safat
Netherlands (1)
Amsterdam
New Zealand (1)
Christchurch
Norway (1)
Bergen
Poland (1)
Poznan
Saudi Arabia (1)
Jeddah
Spain (1)
A Coruña
Sweden (1)
Uppsala
United Kingdom (1)
Birmingham
United States (1)
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
01.07.2015
Completion date
01.04.2027
Registry ID
NCT02536118
Source
anzctr
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