Prevention of Inappropriate ICD Shocks (RISSY-ICD)

January 21, 2014 updated by: Serkan Cay, Yuksek Ihtisas Hospital
The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 2
  • Phase 3

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

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06100
        • Yuksek Ihtisas Hospital

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Conventional
Conventional ICD programming
Device: ICD programming
EXPERIMENTAL: High-zone
High-zone ICD programming
Device: ICD programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First total inappropriate therapy
Time Frame: 12 months
Occurence of first total inappropriate therapy at 12-month follow-up
12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 months
Occurence of all-cause mortality at 12-month follow-up
12 months
Hospitalization for heart failure
Time Frame: 12 months
Occurence of hospitalization for heart failure at 12-month follow-up
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuksek Ihtisas Hospital

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

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (ESTIMATE)

January 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 21, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • SNY-168

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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