Prevention of Inappropriate ICD Shocks

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02044315

Acronym

RISSY-ICD

Enrollment

201

Registered

2014-01-23

Start date

2012-01-31

Completion date

2012-12-31

Last updated

2014-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appropriate ICD Therapy, Inappropriate ICD Therapy

Brief summary

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

Interventions

DEVICEICD programming

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
First total inappropriate therapy	12 months	Occurence of first total inappropriate therapy at 12-month follow-up
Occurence of first total appropriate therapy at 12-month follow-up	12 months	Occurence of first total appropriate therapy at 12-month follow-up

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026