The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
Study Type
OBSERVATIONAL
Enrollment
163
St. Ann University Hospital
Brno, Czechia
CHU de Saint-Etienne
Saint-Etienne, France
Hopital Civil Strasbourg
Strasbourg, France
Rate of appropriate sensing and pacing
The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of the 3-month follow-up.
Time frame: at the 3-month follow-up
Serious adverse device effects (SADEs) related to the SD01 lead
Time frame: until the 3-month follow-up
Comparison of pacing threshold between Linoxsmart and SD01
Comparison of the manually measured pacing threshold of the SD01 lead system to the Linox SD lead at 3-month follow-up. The idea is that the pacing threshold will be similar within a suitable range.
Time frame: at the 3-month follow-up
Shift rate of the painless shock impedance measurement
Time frame: between 3- and 6-month follow-up
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Helios Klinik Aue
Aue, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
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Jena, Germany
University Clinic of Schleswig-Holstein
Lübeck, Germany
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Merseburg, Germany
Städtisches Klinikum München Bogenhausen
München, Germany
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...and 4 more locations