Eluna Family / Sentus BP Master Study

Biotronik

Status: Completed

Conditions: Bradycardia; Heart Failure

Treatments: Device: Sentus BP lead; Device: Eluna pacemaker family

Study type: Observational

Funder types: Industry

Identifiers

NCT02059629

CR014

Details and patient eligibility

About

The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead.

Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is willing to participate in the study and provided written informed consent
• Patient meets standard indication for pacemaker or CRT-P or CRT-D therapy
• Patient accepts Home Monitoring® concept
• Patient has legal capacity and ability to consent

Exclusion criteria

• Patient with any contraindication to pacemaker and CRT-P and CRT-D therapy
• Patient under the age of 18
• Pregnant or breast-feeding women
• Cardiac surgery planned within the next 6 months
• Life expectancy less than 12 months
• Participation in another cardiac clinical investigation with active treatment arm
• Group B only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead (for CRT implants only)

Trial design

167 participants in 2 patient groups

Group A: Eluna pacemaker family

Description:

Patients with standard indication for pacemaker therapy or Cardiac Resynchronization Therapy (CRT), who will be implanted with a pacemaker or CRT device of the Eluna pacemaker family. Single-, Dual- and Tripple-chamber pacemakers are applicable.

Treatment:

Device: Eluna pacemaker family

Group B: Sentus BP lead

Description:

Heart failure patients with indication for Cardiac Resynchronization Therapy (CRT) therapy, who will be implanted with the left ventricular Sentus BP lead. Patients can receive either CRT pacemaker or CRT-D (CRT with defibrillator function).

Treatment:

Device: Sentus BP lead