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Completed

NCT Number: NCT01217528

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

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.

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Key information

Conditions

Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Einrichtungen der RWTH Aachen, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

device settings for group A

Device

VT zone: 350ms VF zone: 280ms

Other names: Control group

Device settings for group B

Device

VT zone: 320ms VF zone: 250ms

Other names: Treatment group

Primary outcomes

  1. Primary Endpoint

    Time frame: 12 months

    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 outcomes

  1. Amount of patients with appropriate / inappropriate ICD therapies

    Time frame: 12 months

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

    Time frame: 12 months

  3. Number and cycle lengths of supraventricular / ventricular tachys

    Time frame: 12 months

  4. Time to first appropriate / inappropriate ICD therapy

    Time frame: 12 months

  5. Sensitivity for diagnosis of sustained VT

    Time frame: 12 months

  6. Specificity for SVT diagnosis

    Time frame: 12 months

  7. Quality of Life (MLHF Questionaire)

    Time frame: 12 months

  8. Overall mortality

    Time frame: 12 months

  9. Cardiac mortality

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: DECREASE

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Oct 8, 2010
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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