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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT00729235
Eligibility Criteria:
Inclusion Criteria:
* Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix §M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
* Patient has signed a consent form after he/she received the appropriate and mandatory information.
Exclusion Criteria:
* Clinical history of symptomatic or not symptomatic slow VT;
* Permanent Atrial Fibrillation (AF);
* Any contraindication to the implant or replacement of CRT-ICD;
* Pt is unable to attend the scheduled f-up visits at the implanting Centre;
* Pt is already included in another ongoing clinical study;
* Pt is unable to understand the objectives of the ITAC04 study;
* Pt refuses to cooperate;
* Pt is unable or refuses to provide informed consent;
* Pt is minor (less than 18-year old);
* Pt has life expectancy of less than 1 year;
* Pt is pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00729235
Study Brief:
Protocol Section:
NCT00729235