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Completed

NCT Number: NCT02059629

Eluna Family / Sentus BP Master Study

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Allgemeines Krankenhaus Linz, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Eluna pacemaker family

Device

New pacemaker generation with new functions, like wandless RF telemetry "SafeSync"

Other names: Eluna SR-T/DR-T/HF-T, Etrinsa SR-T/DR-T/HF-T, Epyra SR-T/DR-T/HF-T

Sentus BP lead

Device

over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead

Other names: Sentus OTW BP L

Primary outcomes

  1. Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate

    Time frame: 6 months

    The safety of the Eluna pacemaker family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.

  2. Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate

    Time frame: 3 months

    The safety of the Sentus BP left ventricular lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the Sentus BP lead will be the basis for endpoint calculation of the SADE free rate.

Other outcomes

  1. Collection of data of interest: Handling assessment of Sentus lead during implantation

    Time frame: 3 months

  2. Collection of further data of interest: Evaluation of wandless RF telemetry function "SafeSync" in the Eluna pacemaker family

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2014
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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