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 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT01717495
Eligibility Criteria:
Inclusion Criteria:
* Older than 18 years
* Pacemaker/ implantable-cardioverter defibrillator (ICD) / cardiac resynchronization therapy (CRT) initial implant by transvenous approach or
* Patients submitted to reoperation procedures, as: pulse generator replacement, implant of an additional lead, lead extraction, lead repositioning;
* Subject agreed to participate and signed the consent form
Exclusion Criteria:
* Patients with a history of venous thromboembolism, coagulopathy or malignancy
* Pregnancy
* Life expectancy of less than one year
* Contraindication to administration of iodinated contrast (creatinine \> 3.0)
* Unable to attend the follow-up appointments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01717495
Study Brief:
Protocol Section:
NCT01717495