Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by * demonstrating clinical safety * evaluating performance based on sensing and pacing assessment * collecting additional data of interest to assess other aspects such as the handling and usability
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
221
Implantation, measurements and follow-up schedule
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Pamira lead related SADE-d free rate at 6 months after implantation
Time frame: 6 months
1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation
Time frame: 3 months, 12 months
2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up
Time frame: 6 months, 12 months
3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up
Time frame: 6 months, 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medizinische Universität Graz
Graz, Styria, Austria
UZ Brussels
Jette, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum der Universität München
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus, North Rhine-Westphalia, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Saxony, Germany
...and 13 more locations