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DECREASE: Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01217528
Collaborator
(none)
543
Enrollment
34
Locations
2
Arms
41
Duration (Months)
16
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.

Condition or Disease Intervention/Treatment Phase
  • Device: device settings for group A
  • Device: Device settings for group B
 N/A

Detailed Description

Inappropriate ICD therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk.

It's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.

Study Design

Study Type:
Interventional
Actual Enrollment :
543 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reduction of Inappropriate ICD Therapies in Patients With Approved Indication for Primary Prevention of Sudden Cardiac Death
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

Group A: VT zone: 350ms VF zone: 280ms

Device: device settings for group A
VT zone: 350ms VF zone: 280ms
Other Names:
  • Control group

    		•
    Experimental: Group B

    Group B: VT zone: 320ms VF zone: 250ms

    Device: Device settings for group B
    VT zone: 320ms VF zone: 250ms
    Other Names:
  • Treatment group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Endpoint [12 months]

      Event free survival of: inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND spontaneous, documented, sustained (>30s) ventricular tachycardia, that was not treated by the ICD

    Secondary Outcome Measures

    1. Amount of patients with appropriate / inappropriate ICD therapies [12 months]

    2. Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD [12 months]

    3. Number and cycle lengths of supraventricular / ventricular tachys [12 months]

    4. Time to first appropriate / inappropriate ICD therapy [12 months]

    5. Sensitivity for diagnosis of sustained VT [12 months]

    6. Specificity for SVT diagnosis [12 months]

    7. Quality of Life (MLHF Questionaire) [12 months]

    8. Overall mortality [12 months]

    9. Cardiac mortality [12 months]

    10. Frequency and efficacy of ATP prior to / before capacitor charging in VF zone [12 months]

    11. Amount of patients with appropriate / inappropriate shocks or ATP [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Approved indication for new ICD implantation for primary prevention of sudden cardiac death

    • Age >=18 Years

    • Written informed consent

    Exclusion Criteria:

    • ICD indication for secondary prevention reasons

    • ICD indication for "electrical" disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)

    • ICD change or upgrade

    • Pregnancy

    • Nonage

    • Patient is already participating to another study with active therapy arm

    • Patient will most likely not be able to participate to the routine follow ups in the study center.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medizinische Einrichtungen der RWTH Aachen Aachen Germany 52074
    2 Klinikum Altenburger Land GmbH Altenburg Germany 04600
    3 Städtisches Krankenhaus St. Barbara Attendorn GmbH Attendorn Germany 57439
    4 Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität Bonn Germany 53127
    5 Klinikum Coburg Coburg Germany 96450
    6 Klinik Fränkische Schweiz Ebermannstadt Germany 91320
    7 Kreiskrankenhaus Ebersberg Ebersberg Germany 85560
    8 Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang Erfurt Germany 99084
    9 Klinikum Esslingen Esslingen Germany 73730
    10 Universitätsklinik Freiburg Freiburg Germany 79106
    11 Krankenhaus Waltershausen-Friedrichroda Friedrichroda Germany 99894
    12 Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen Gießen Germany 35392
    13 Asklepios Klinik St. Georg Hamburg Germany 20099
    14 Universitäres Herzzentrum Hamburg Hamburg Germany 20246
    15 Oberhavel Kliniken GmbH Klinik Hennigsdorf Henningsdorf Germany 16761
    16 Universitätsklinikum Schleswig-Holstein Campus Kiel Kiel Germany 24105
    17 Frankenwaldklinik Kronach GmbH Kronach Germany 96317
    18 Evangelisches Krankenhaus Kalk Köln Germany 51103
    19 Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Germany 67063
    20 St.-Marien-Hospital GmbH Lünen Germany 44534
    21 Klinikum Memmingen Memmingen Germany 87700
    22 Klinikum Großhadern der Ludwig-Maximilians-Universität München München Germany 81377
    23 Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber München Germany 81379
    24 Universitätsklinikum Münster Münster Germany 48149
    25 Praxis Dres. med. Haggenmiller / Jeserich Nürnberg Germany 90402
    26 Klinikum Nürnberg Nürnberg Germany 90471
    27 Kreiskrankenhaus des Bördekreises Krankenhaus 4 Oschersleben Germany 39387
    28 Niels-Stensen-Kliniken Marienhospital Osnabrück Osnabrück Germany 49074
    29 Klinikum Pirna GmbH Klinik für Innere Medizin II Pirna Germany 01796
    30 Klinikum Dorothea Christiane Erxleben GmbH Quedlinburg Germany 06484
    31 Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes Ratzeburg Germany 23909
    32 Universität Rostock Rostock Germany 18057
    33 Katharinen-Hospital gGmbH Unna Germany 59423
    34 Helios Klinikum Wuppertal Wuppertal Germany 42117

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: Jörg O Schwab, Prof. Dr. med., Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität Bonn

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01217528
    Other Study ID Numbers:
    • T76
    First Posted:
    Oct 8, 2010
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Abbott Medical Devices
    ICD
    CRTD
    Sudden cardiac death
    Device settings
    Patients who received ICD/CRTD for primary prevention of sudden cardiac death
    Additional relevant MeSH terms:
    Death

    Study Results

    No Results Posted as of Feb 4, 2019