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Cardiac DeathDECREASENCT01217528

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

A study testing device settings for group A and Device settings for group B in people with Cardiac Death, run by Abbott Medical Devices at 34 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Death
What is being tested?
device settings for group A and Device settings for group B
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
543 participants
Where
34 sitesGermany
Study dates
Aug 2009to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Germany34 sites

  • Medizinische Einrichtungen der RWTH Aachen

    Aachen, 52074

  • Klinikum Altenburger Land GmbH

    Altenburg, 04600

  • Städtisches Krankenhaus St. Barbara Attendorn GmbH

    Attendorn, 57439

  • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität

    Bonn, 53127

  • Klinikum Coburg

    Coburg, 96450

  • Evangelisches Krankenhaus Kalk

    Cologne, 51103

  • Klinik Fränkische Schweiz

    Ebermannstadt, 91320

  • Kreiskrankenhaus Ebersberg

    Ebersberg, 85560

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

    Erfurt, 99084

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Universitätsklinik Freiburg

    Freiburg im Breisgau, 79106

  • Krankenhaus Waltershausen-Friedrichroda

    Friedrichroda, 99894

  • Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen

    Giessen, 35392

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitäres Herzzentrum Hamburg

    Hamburg, 20246

  • Oberhavel Kliniken GmbH Klinik Hennigsdorf

    Henningsdorf, 16761

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Frankenwaldklinik Kronach GmbH

    Kronach, 96317

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063

  • St.-Marien-Hospital GmbH

    Lünen, 44534

  • Klinikum Memmingen

    Memmingen, 87700

  • Klinikum Großhadern der Ludwig-Maximilians-Universität München

    München, 81377

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

    München, 81379

  • Universitätsklinikum Münster

    Münster, 48149

  • Praxis Dres. med. Haggenmiller / Jeserich

    Nuremberg, 90402

  • Klinikum Nürnberg

    Nuremberg, 90471

  • Kreiskrankenhaus des Bördekreises Krankenhaus 4

    Oschersleben, 39387

  • Niels-Stensen-Kliniken Marienhospital Osnabrück

    Osnabrück, 49074

  • Klinikum Pirna GmbH Klinik für Innere Medizin II

    Pirna, 01796

  • Klinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg, 06484

  • Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes

    Ratzeburg, 23909

  • Universität Rostock

    Rostock, 18057

  • Katharinen-Hospital gGmbH

    Unna, 59423

  • Helios Klinikum Wuppertal

    Wuppertal, 42117

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Cardiac Death
Being tested
device settings for group A, Device settings for group B
Keywords
ICD, CRTD, Sudden cardiac death, Device settings, Patients who received ICD/CRTD for primary prevention of sudden cardiac death
Medical subject headings
Death, Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • device settings for group ADevice

    Also called Control group

    VT zone: 350ms VF zone: 280ms

  • Device settings for group BDevice

    Also called Treatment group

    VT zone: 320ms VF zone: 250ms

Study groups in NCT01217528
Study groupRoleWhat they receive
Group AActive comparatorGroup A: * VT zone: 350ms * VF zone: 280ms
Receives: Device: device settings for group A
Group BExperimentalGroup B: * VT zone: 320ms * VF zone: 250ms
Receives: Device: Device settings for group B

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (11)

  1. Amount of patients with appropriate / inappropriate ICD therapies

    Measured: 12 months

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

    Measured: 12 months

  3. Number and cycle lengths of supraventricular / ventricular tachys

    Measured: 12 months

  4. Time to first appropriate / inappropriate ICD therapy

    Measured: 12 months

  5. Sensitivity for diagnosis of sustained VT

    Measured: 12 months

  6. Specificity for SVT diagnosis

    Measured: 12 months

  7. Quality of Life (MLHF Questionaire)

    Measured: 12 months

  8. Overall mortality

    Measured: 12 months

  9. Cardiac mortality

    Measured: 12 months

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

    Measured: 12 months

  11. Amount of patients with appropriate / inappropriate shocks or ATP

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2010 (estimated)
  2. Study startAug 2009
  3. Primary completionSep 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01217528
Sponsor's protocol ID
T76
Acronym
DECREASE
Status last verified
Feb 2019
First submitted
10 Sep 2010
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26002818

Questions about this trial

What is this clinical trial studying?

A study testing device settings for group A and Device settings for group B in people with Cardiac Death, run by Abbott Medical Devices at 34 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01217528, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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