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

February 1, 2019 updated by: Abbott Medical Devices

Reduction of Inappropriate ICD Therapies in Patients With Approved Indication for Primary Prevention of Sudden Cardiac Death

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

543

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Medizinische Einrichtungen der RWTH Aachen
      • Altenburg, Germany, 04600
        • Klinikum Altenburger Land GmbH
      • Attendorn, Germany, 57439
        • Städtisches Krankenhaus St. Barbara Attendorn GmbH
      • Bonn, Germany, 53127
        • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Ebermannstadt, Germany, 91320
        • Klinik Fränkische Schweiz
      • Ebersberg, Germany, 85560
        • Kreiskrankenhaus Ebersberg
      • Erfurt, Germany, 99084
        • Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
      • Esslingen, Germany, 73730
        • Klinikum Esslingen
      • Freiburg, Germany, 79106
        • Universitätsklinik Freiburg
      • Friedrichroda, Germany, 99894
        • Krankenhaus Waltershausen-Friedrichroda
      • Gießen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Hamburg
      • Henningsdorf, Germany, 16761
        • Oberhavel Kliniken GmbH Klinik Hennigsdorf
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Kronach, Germany, 96317
        • Frankenwaldklinik Kronach GmbH
      • Köln, Germany, 51103
        • Evangelisches Krankenhaus Kalk
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Lünen, Germany, 44534
        • St.-Marien-Hospital GmbH
      • Memmingen, Germany, 87700
        • Klinikum Memmingen
      • München, Germany, 81377
        • Klinikum Großhadern der Ludwig-Maximilians-Universität München
      • München, Germany, 81379
        • Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Nürnberg, Germany, 90471
        • Klinikum Nürnberg
      • Nürnberg, Germany, 90402
        • Praxis Dres. med. Haggenmiller / Jeserich
      • Oschersleben, Germany, 39387
        • Kreiskrankenhaus des Bördekreises Krankenhaus 4
      • Osnabrück, Germany, 49074
        • Niels-Stensen-Kliniken Marienhospital Osnabrück
      • Pirna, Germany, 01796
        • Klinikum Pirna GmbH Klinik für Innere Medizin II
      • Quedlinburg, Germany, 06484
        • Klinikum Dorothea Christiane Erxleben GmbH
      • Ratzeburg, Germany, 23909
        • Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes
      • Rostock, Germany, 18057
        • Universität Rostock
      • Unna, Germany, 59423
        • Katharinen-Hospital gGmbH
      • Wuppertal, Germany, 42117
        • Helios Klinikum Wuppertal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Time Frame
Overall mortality
Time Frame: 12 months
12 months
Amount of patients with appropriate / inappropriate ICD therapies
Time Frame: 12 months
12 months
Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD
Time Frame: 12 months
12 months
Number and cycle lengths of supraventricular / ventricular tachys
Time Frame: 12 months
12 months
Time to first appropriate / inappropriate ICD therapy
Time Frame: 12 months
12 months
Sensitivity for diagnosis of sustained VT
Time Frame: 12 months
12 months
Specificity for SVT diagnosis
Time Frame: 12 months
12 months
Quality of Life (MLHF Questionaire)
Time Frame: 12 months
12 months
Cardiac mortality
Time Frame: 12 months
12 months
Frequency and efficacy of ATP prior to / before capacitor charging in VF zone
Time Frame: 12 months
12 months
Amount of patients with appropriate / inappropriate shocks or ATP
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T76

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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