search
Back to results

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

Primary Purpose

Cardiac Death

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
device settings for group A
Device settings for group B
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Death focused on measuring ICD, CRTD, Sudden cardiac death, Device settings, Patients who received ICD/CRTD for primary prevention of sudden cardiac death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medizinische Einrichtungen der RWTH Aachen
  • Klinikum Altenburger Land GmbH
  • Städtisches Krankenhaus St. Barbara Attendorn GmbH
  • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
  • Klinikum Coburg
  • Klinik Fränkische Schweiz
  • Kreiskrankenhaus Ebersberg
  • Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
  • Klinikum Esslingen
  • Universitätsklinik Freiburg
  • Krankenhaus Waltershausen-Friedrichroda
  • Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
  • Asklepios Klinik St. Georg
  • Universitäres Herzzentrum Hamburg
  • Oberhavel Kliniken GmbH Klinik Hennigsdorf
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • Frankenwaldklinik Kronach GmbH
  • Evangelisches Krankenhaus Kalk
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • St.-Marien-Hospital GmbH
  • Klinikum Memmingen
  • Klinikum Großhadern der Ludwig-Maximilians-Universität München
  • Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber
  • Universitätsklinikum Münster
  • Praxis Dres. med. Haggenmiller / Jeserich
  • Klinikum Nürnberg
  • Kreiskrankenhaus des Bördekreises Krankenhaus 4
  • Niels-Stensen-Kliniken Marienhospital Osnabrück
  • Klinikum Pirna GmbH Klinik für Innere Medizin II
  • Klinikum Dorothea Christiane Erxleben GmbH
  • Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes
  • Universität Rostock
  • Katharinen-Hospital gGmbH
  • Helios Klinikum Wuppertal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Primary Endpoint
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

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

Full Information

First Posted
September 10, 2010
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT01217528
Brief Title
Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
Acronym
DECREASE
Official Title
Reduction of Inappropriate ICD Therapies in Patients With Approved Indication for Primary Prevention of Sudden Cardiac Death
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Death
Keywords
ICD, CRTD, Sudden cardiac death, Device settings, Patients who received ICD/CRTD for primary prevention of sudden cardiac death

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A: VT zone: 350ms VF zone: 280ms
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B: VT zone: 320ms VF zone: 250ms
Intervention Type
Device
Intervention Name(s)
device settings for group A
Other Intervention Name(s)
Control group
Intervention Description
VT zone: 350ms VF zone: 280ms
Intervention Type
Device
Intervention Name(s)
Device settings for group B
Other Intervention Name(s)
Treatment group
Intervention Description
VT zone: 320ms VF zone: 250ms
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Amount of patients with appropriate / inappropriate ICD therapies
Time Frame
12 months
Title
Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD
Time Frame
12 months
Title
Number and cycle lengths of supraventricular / ventricular tachys
Time Frame
12 months
Title
Time to first appropriate / inappropriate ICD therapy
Time Frame
12 months
Title
Sensitivity for diagnosis of sustained VT
Time Frame
12 months
Title
Specificity for SVT diagnosis
Time Frame
12 months
Title
Quality of Life (MLHF Questionaire)
Time Frame
12 months
Title
Overall mortality
Time Frame
12 months
Title
Cardiac mortality
Time Frame
12 months
Title
Frequency and efficacy of ATP prior to / before capacitor charging in VF zone
Time Frame
12 months
Title
Amount of patients with appropriate / inappropriate shocks or ATP
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg O Schwab, Prof. Dr. med.
Organizational Affiliation
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Einrichtungen der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum Altenburger Land GmbH
City
Altenburg
ZIP/Postal Code
04600
Country
Germany
Facility Name
Städtisches Krankenhaus St. Barbara Attendorn GmbH
City
Attendorn
ZIP/Postal Code
57439
Country
Germany
Facility Name
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Klinik Fränkische Schweiz
City
Ebermannstadt
ZIP/Postal Code
91320
Country
Germany
Facility Name
Kreiskrankenhaus Ebersberg
City
Ebersberg
ZIP/Postal Code
85560
Country
Germany
Facility Name
Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
City
Erfurt
ZIP/Postal Code
99084
Country
Germany
Facility Name
Klinikum Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Universitätsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Krankenhaus Waltershausen-Friedrichroda
City
Friedrichroda
ZIP/Postal Code
99894
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Oberhavel Kliniken GmbH Klinik Hennigsdorf
City
Henningsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Frankenwaldklinik Kronach GmbH
City
Kronach
ZIP/Postal Code
96317
Country
Germany
Facility Name
Evangelisches Krankenhaus Kalk
City
Köln
ZIP/Postal Code
51103
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
St.-Marien-Hospital GmbH
City
Lünen
ZIP/Postal Code
44534
Country
Germany
Facility Name
Klinikum Memmingen
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Klinikum Großhadern der Ludwig-Maximilians-Universität München
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber
City
München
ZIP/Postal Code
81379
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Praxis Dres. med. Haggenmiller / Jeserich
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Kreiskrankenhaus des Bördekreises Krankenhaus 4
City
Oschersleben
ZIP/Postal Code
39387
Country
Germany
Facility Name
Niels-Stensen-Kliniken Marienhospital Osnabrück
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Klinikum Pirna GmbH Klinik für Innere Medizin II
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Klinikum Dorothea Christiane Erxleben GmbH
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes
City
Ratzeburg
ZIP/Postal Code
23909
Country
Germany
Facility Name
Universität Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Katharinen-Hospital gGmbH
City
Unna
ZIP/Postal Code
59423
Country
Germany
Facility Name
Helios Klinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26002818
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs