Clinical trial NCT02059629: Eluna Family / Sentus BP Master Study
Official title: Eluna Family / Sentus BP Master Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Heart Failure
Keywords: Heart failure
Eluna pacemaker family
Sentus OTW BP L left ventricular lead
Bradycardia
SADE-free rate
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from available pacemaker or CRT patients directly by the treating physician at the investigational site

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate
timeFrame: 6 months
measure: Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Collection of data of interest: Handling assessment of Sentus lead during implantation
timeFrame: 3 months
measure: Collection of further data of interest: Evaluation of wandless RF telemetry function "SafeSync" in the Eluna pacemaker family
timeFrame: 6 months
Locations:
city: Linz
country: Austria
facility: Allgemeines Krankenhaus Linz
city: Arlon
country: Belgium
facility: Cliniques du Sud Luxembourg
city: Genk
country: Belgium
facility: ZOL Genk
city: Aalborg
country: Denmark
facility: Aalborg Sygehus
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum
city: Detmold
country: Germany
facility: Klinikum Lippe
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Medizinische Klinik 2
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Lünen
country: Germany
facility: St. Marien-Hospital Lünen
city: Saarlouis
country: Germany
facility: Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: Cliniques du Sud Luxembourg
name: Georges Mairesse, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: