The conventional CRT-D system consists of 3 leads in patients with Heart Failure (HF). A part of HF patients have non-impaired sinus node function and will not be stimulated in the right atrium. The implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. The new CRT-DX system uses 2 leads only: a right ventricular lead extended with floating RA sending dipole and a left ventricular lead. The aim of the BIO\|REDUCE study is to assess the residual safety and performance aspects of the CRT-DX system within 12 months follow-up in HF patients with an indication for a CRT-D, sinus rhythm, and no need for an atrial lead implantation.
Study Type
OBSERVATIONAL
Enrollment
113
Observation and documentation of CRT patients
Kepler University Clinic
Linz, Austria
Fakultni Nemocnice Hradec Králové
Králová, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, Germany
Vivantes Humboldt-Klinikum
Berlin, Germany
Herzzentrum Dresden Univesity Clinic at Technical University Dresden
Dresden, Germany
Städtisches Klinikum Dresden, Friedrichstadt
Dresden, Germany
Heinrich-Heine University Düsseldorf
Düsseldorf, Germany
University Clinic Erlangen
Erlangen, Germany
Elisabeth-Krankenhaus Essen
Essen, Germany
...and 11 more locations
Number of implantation of a right atrial lead after conclusion of the initial study device implantation
Time frame: through study completion, on average 12 months
Number of post-operative system revisions requiring an invasive re-intervention
Time frame: through study completion, on average 12 months
Number of lead complications requiring an invasive re-intervention
Time frame: through study completion, on average 12 months
Number of device or pocket infections requiring an invasive re-intervention
Time frame: through study completion, on average 12 months
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