Eluna Family / Sentus BP Master Study

Heart Failure Clinical Trial

Official title:

Eluna Family / Sentus BP Master Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059629
• Other study ID #: CR014
• Status: Completed
• Phase: N/A
• First received: February 7, 2014
• Last updated: May 23, 2016
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Austrian Medicines and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure

Intervention

Device:
• Eluna pacemaker family
New pacemaker generation with new functions, like wandless RF telemetry "SafeSync"
• Sentus BP lead
over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus Linz	Linz
Belgium	Cliniques du Sud Luxembourg	Arlon
Belgium	ZOL Genk	Genk
Denmark	Aalborg Sygehus	Aalborg
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense University Hospital	Odense
Germany	Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum	Berlin
Germany	Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin	Berlin
Germany	Klinikum Lippe	Detmold
Germany	Universitätsklinikum Erlangen, Medizinische Klinik 2	Erlangen
Germany	Elisabeth Krankenhaus Essen	Essen
Germany	Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen	Essen
Germany	Universitäts-Herzzentrum Freiburg	Freiburg
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	St. Marien-Hospital Lünen	Lünen
Germany	Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis	Saarlouis
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Germany,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collection of data of interest: Handling assessment of Sentus lead during implantation		3 months	No
Other	Collection of further data of interest: Evaluation of wandless RF telemetry function "SafeSync" in the Eluna pacemaker family		6 months	No
Primary	Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate	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.	6 months	Yes
Primary	Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate	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.	3 months	Yes