Efface: Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01244308
Collaborator
(none)
132
10
41
13.2
0.3

Study Details

Study Description

Brief Summary

It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    132 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in CRT Patients
    Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2009
    Actual Study Completion Date :
    Aug 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Amount of patients with at least one acceptable LV pacing configuration. [First Follow Up after hospital discharge (approx. 1-3 months)]

      Amount of patients with at least one acceptable, programmable LV pacing configuration. Definition of acceptable LV pacing configuration: LV pacing threshold <=2.5V@0.5ms AND Phrenic nerve threshold is at least twice as high as LV pacing threshold AND LV pacing impedance >=200 Ohms. Only patients with implanted CRT-D and bipolar leftventricular lead are taken into account.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • indication for CRT-D implantation / upgrade

    • written informed consent

    Exclusion Criteria:
    • pregnancy

    • age < 18 years

    • patients, who cannot visit the routine follow ups (within first 3.5months)

    • participants to other studies with active treatment arm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medizinische Einrichtungen der RWTH Aachen Aachen Germany 52074
    2 Hufeland Klinikum GmbH Bad Langensalza Germany 99947
    3 Cardioangiologisches Centrum Bethanien Frankfurt am Main Germany 60389
    4 Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen Gießen Germany 35392
    5 Universitäres Herzzentrum Hamburg GmbH (UHZ) Hamburg Germany 20246
    6 Katholisches Krankenhaus Marienhospital Universitätsklinik Herne Germany 44625
    7 Klinikum Kassel gGmbH Kassel Germany 34125
    8 Universitätsklinikum Leipzig AÖR Leipzig Germany 04103
    9 Niels-Stensen-Kliniken Marienhospital Osnabrück Germany 49074
    10 Klinikum Dorothea Christiane Erxleben GmbH Quedlinburg Germany 06484

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: Norbert Klein, Dr. med., Universitätsklinikum Leipzig AÖR

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01244308
    Other Study ID Numbers:
    • T86
    First Posted:
    Nov 19, 2010
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Abbott Medical Devices
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2019