Evia/Entovis HF-T Master Study

Biotronik

Status: Completed

Conditions: Indication for Cardiac Resynchronization Therapy (CRT)

Treatments: Device: Evia/Entovis HF-T pacemaker for CRT therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01545739

57

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

122 participants in 1 patient group

CRT pacemaker implantation

Treatment:

Device: Evia/Entovis HF-T pacemaker for CRT therapy