Eluna Family / Sentus BP Master Study

NCT02059629 | Completed

• 1 other identifier: CR014
• Study Type: observational
• Target: 167
• Locations: 5 countries
• Sites: 17

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.

Conditions

Bradycardia; Heart Failure

Keywords

Heart failure; Eluna pacemaker family; Sentus OTW BP L left ventricular lead; Bradycardia; SADE-free rate

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (2)

• Collection of data of interest: Handling assessment of Sentus lead during implantation

  3 months

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

  6 months

Study Arms (2)

Group A: Eluna pacemaker family

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.

Device: Eluna pacemaker family

Group B: Sentus BP lead

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).

Device: Sentus BP lead

Interventions

Eluna pacemaker family DEVICE

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

Also known as: Eluna SR-T/DR-T/HF-T, Etrinsa SR-T/DR-T/HF-T, Epyra SR-T/DR-T/HF-T

Group A: Eluna pacemaker family

Sentus BP lead DEVICE

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

Also known as: Sentus OTW BP L

Group B: Sentus BP lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (17)

Allgemeines Krankenhaus Linz

Linz, 4020, Austria

Location

Cliniques du Sud Luxembourg

Arlon, 6700, Belgium

Location

ZOL Genk

Genk, 3600, Belgium

Location

Aalborg Sygehus

Aalborg, 9000, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Klinikum Lippe

Detmold, 32756, Germany

Location

Universitätsklinikum Erlangen, Medizinische Klinik 2

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen

Essen, 45122, Germany

Location

Elisabeth Krankenhaus Essen

Essen, 45138, Germany

Location

Universitäts-Herzzentrum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

St. Marien-Hospital Lünen

Lünen, 44534, Germany

Location

Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis

Saarlouis, 66740, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Bradycardia; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Georges Mairesse, Dr. med

  Cliniques du Sud Luxembourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

AU (1); DK (3); DE (10); BE (2); HK (1)