Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications (Prediction)

LivaNova

Status and phase: Completed; Phase 4

Conditions: Sudden Cardiac Death

Treatments: Device: Ovatio VR 6250 or DR6550

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560768

Prediction - ITAC06 Eu

ITAC06 Eu

Details and patient eligibility

About

The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.

Enrollment: 198 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines

• CHF since > 3 months and
• LVEF < 35% and
• NYHA class II or III

OR

• Prior Myocardial infarction since more than 4 weeks and
• LVEF < 30%

Exclusion criteria

• Documented spontaneous sustained ventricular tachycardia
• Prior implant of any device for ventricular cardiac pacing
• Existing indication for permanent ventricular pacing
• Myocardial infarction within 4 weeks prior to enrollment
• Arrhythmogenic RV-Dysplasia
• Brugada syndrome
• Long QT syndrome
• Performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical)
• Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
• Excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient
• Permanent chronic atrial fibrillation / flutter
• Patient is unable to attend the scheduled follow-up visits at the participating centre
• Patient is already included in another ongoing clinical study
• Patient is unable to understand the objectives of the study
• Patient refuses to cooperate
• Patient is unable or refuses to provide informed consent
• Patient is minor (less than 18-year old)
• Patient has life expectancy of less than 1 year
• Patient is pregnant.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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198 participants in 1 patient group

1

Experimental group

Treatment:

Device: Ovatio VR 6250 or DR6550