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OpenTrials
Completed

NCT Number: NCT02044315

Prevention of Inappropriate ICD Shocks

The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.

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Key information

Conditions

Inappropriate ICD Therapy Appropriate ICD Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yuksek Ihtisas Hospital

Ankara, Cankaya, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 years
  • Cardiomyopathy (ischemic or not)
  • Current accepted indication for ICD implantation

Exclusion criteria

  • Previous device implantation
  • Secondary prevention patients
  • Pregnancy,
  • Primary electrical disorders,
  • Patient refusal,
  • <1 year of expected mortality

Treatment and study plan

ICD programming

Device

Primary outcomes

  1. First total inappropriate therapy

    Time frame: 12 months

    Occurence of first total inappropriate therapy at 12-month follow-up

  2. Occurence of first total appropriate therapy at 12-month follow-up

    Time frame: 12 months

    Occurence of first total appropriate therapy at 12-month follow-up

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 months

    Occurence of all-cause mortality at 12-month follow-up

  2. Hospitalization for heart failure

    Time frame: 12 months

    Occurence of hospitalization for heart failure at 12-month follow-up

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas Hospital

Other

Registry information

Acronym: RISSY-ICD

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2014
Registry last updated
Jan 23, 2014

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.