Prevention of Inappropriate ICD Shocks

Phase 2

Completed

• Conditions: Inappropriate ICD Therapy; Appropriate ICD Therapy
• Interventions: Device: ICD programming

• Registration Number: NCT02044315
• Lead Sponsor: Yuksek Ihtisas Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Last Update Submitted: 2014-01-21
• Study First Posted: 2014-01-23
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-zone	ICD programming	High-zone ICD programming
Conventional	ICD programming	Conventional ICD programming

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yuksek Ihtisas Hospital; 🇹🇷 Ankara, Cankaya, Turkey