Prevention of Inappropriate ICD Shocks

Phase 3CompletedNCT02044315

Yuksek Ihtisas Hospital201 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

201

Conditions

Inappropriate ICD Therapy Appropriate ICD Therapy

Interventions

ICD programmingDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yuksek Ihtisas Hospital

Ankara, Cankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

First total inappropriate therapy

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

Time frame: 12 months

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

Time frame: 12 months

Secondary Outcomes

All-cause mortality

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

Time frame: 12 months

Hospitalization for heart failure

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

Time frame: 12 months

Data from ClinicalTrials.gov

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