Prevention of Inappropriate ICD Shocks (RISSY-ICD)

Yuksek Ihtisas Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Appropriate ICD Therapy; Inappropriate ICD Therapy

Treatments: Device: ICD programming

Study type: Interventional

Funder types: Other

Identifiers

NCT02044315

SNY-168

Details and patient eligibility

About

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

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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201 participants in 2 patient groups

Conventional

Sham Comparator group

Description:

Conventional ICD programming

Treatment:

Device: ICD programming

High-zone

Experimental group

Description:

High-zone ICD programming

Treatment:

Device: ICD programming