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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01193634
Eligibility Criteria:
Inclusion Criteria:
* In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
* In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
* In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;
Exclusion Criteria:
* 1 VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
* 2 VT/VF occurred during the acute phase of infarction (\< 3 weeks) or during an unstable ischemic phase;
* 3 VF was caused by electrocution;
* 4 Incessant VT/VF ;
* 5 Implanted pacemaker that is not going to be explanted or otherwise disabled;
* 6 Patient is unable to attend the scheduled follow-ups at the implanting centre;
* 7 Patient is already enrolled in another ongoing clinical study;
* 8 Patient is unable to understand the aim of the study and its procedure;
* 9 Patient refuses to cooperate;
* 10 Patient is unable or refuses to provide informed consent;
* 11 Patient is minor (less than 18-year old);
* 12 Patient is pregnant;
* 13 Patient has life expectancy of less than 1 year;
* 14 Patient is forfeiture of freedom or under guardianship.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01193634
Study Brief:
Protocol Section:
NCT01193634