Evia/Entovis HF-T Master Study

Master Study of the Evia/Entovis HF-T Pacemaker

The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.

Inclusion Criteria:

• Standard indication for CRT therapy
• Legal capacity and ability to consent
• Signed patient informed consent

Exclusion Criteria:

• Contraindication for CRT therapy
• ICD indication
• Age < 18 years
• Pregnant or breast-feeding woman
• Cardiac surgery planned within the next 6 months
• Life expectancy of less than 6 months
• Participating in another clinical study of an investigational cardiac drug or device