NCT01217528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

3.1 years

First QC Date

September 10, 2010

Last Update Submit

February 1, 2019

Conditions

Cardiac Death

Keywords

ICDCRTDSudden cardiac deathDevice settingsPatients who received ICD/CRTD for primary prevention of sudden cardiac death

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint

    Event free survival of: 1. inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND 2. spontaneous, documented, sustained (\>30s) ventricular tachycardia, that was not treated by the ICD

    12 months

Secondary Outcomes (11)

  • Amount of patients with appropriate / inappropriate ICD therapies

    12 months

  • Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD

    12 months

  • Number and cycle lengths of supraventricular / ventricular tachys

    12 months

  • Time to first appropriate / inappropriate ICD therapy

    12 months

  • Sensitivity for diagnosis of sustained VT

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Device: device settings for group A

Group B

EXPERIMENTAL

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

Device: Device settings for group B

Interventions

device settings for group ADEVICE

VT zone: 350ms VF zone: 280ms

Also known as: Control group
Group A
Device settings for group BDEVICE

VT zone: 320ms VF zone: 250ms

Also known as: Treatment group
Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Approved indication for new ICD implantation for primary prevention of sudden cardiac death
  • Age \>=18 Years
  • Written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Medizinische Einrichtungen der RWTH Aachen

Aachen, 52074, Germany

Location

Klinikum Altenburger Land GmbH

Altenburg, 04600, Germany

Location

Städtisches Krankenhaus St. Barbara Attendorn GmbH

Attendorn, 57439, Germany

Location

Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität

Bonn, 53127, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Evangelisches Krankenhaus Kalk

Cologne, 51103, Germany

Location

Klinik Fränkische Schweiz

Ebermannstadt, 91320, Germany

Location

Kreiskrankenhaus Ebersberg

Ebersberg, 85560, Germany

Location

Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang

Erfurt, 99084, Germany

Location

Klinikum Esslingen

Esslingen am Neckar, 73730, Germany

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Krankenhaus Waltershausen-Friedrichroda

Friedrichroda, 99894, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen

Giessen, 35392, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Oberhavel Kliniken GmbH Klinik Hennigsdorf

Henningsdorf, 16761, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Frankenwaldklinik Kronach GmbH

Kronach, 96317, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, 67063, Germany

Location

St.-Marien-Hospital GmbH

Lünen, 44534, Germany

Location

Klinikum Memmingen

Memmingen, 87700, Germany

Location

Klinikum Großhadern der Ludwig-Maximilians-Universität München

München, 81377, Germany

Location

Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber

München, 81379, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Praxis Dres. med. Haggenmiller / Jeserich

Nuremberg, 90402, Germany

Location

Klinikum Nürnberg

Nuremberg, 90471, Germany

Location

Kreiskrankenhaus des Bördekreises Krankenhaus 4

Oschersleben, 39387, Germany

Location

Niels-Stensen-Kliniken Marienhospital Osnabrück

Osnabrück, 49074, Germany

Location

Klinikum Pirna GmbH Klinik für Innere Medizin II

Pirna, 01796, Germany

Location

Klinikum Dorothea Christiane Erxleben GmbH

Quedlinburg, 06484, Germany

Location

Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes

Ratzeburg, 23909, Germany

Location

Universität Rostock

Rostock, 18057, Germany

Location

Katharinen-Hospital gGmbH

Unna, 59423, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, 42117, Germany

Location

Related Publications (1)

  • Schwab JO, Bonnemeier H, Kleemann T, Brachmann J, Fischer S, Birkenhauer F, Eberhardt F. Reduction of inappropriate ICD therapies in patients with primary prevention of sudden cardiac death: DECREASE study. Clin Res Cardiol. 2015 Dec;104(12):1021-32. doi: 10.1007/s00392-015-0870-z. Epub 2015 May 23.

    PMID: 26002818DERIVED

MeSH Terms

Conditions

DeathDeath, Sudden, Cardiac

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestHeart DiseasesCardiovascular DiseasesDeath, Sudden

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jörg O Schwab, Prof. Dr. med.

    Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2010

First Posted

October 8, 2010

Study Start

August 1, 2009

Primary Completion

September 1, 2012

Study Completion

January 1, 2013

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

DE(34)