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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
543

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitares 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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