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

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Abbott

Status

Completed

Conditions

Cardiac Death

Treatments

Device: Device settings for group B
Device: device settings for group A

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

543 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

543 participants in 2 patient groups

Group A
Active Comparator group
Description:
Group A: * VT zone: 350ms * VF zone: 280ms
Treatment:
Device: device settings for group A
Group B
Experimental group
Description:
Group B: * VT zone: 320ms * VF zone: 250ms
Treatment:
Device: Device settings for group B

Trial contacts and locations

34

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Data sourced from clinicaltrials.gov

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