Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT00560768
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00560768
Study Brief:
Protocol Section:
NCT00560768