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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT04904393
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female, aged 18 or older;
* chronic heart failure with symptomatic left ventricular systolic function (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
* Appropriate and optimized medical therapy;
* Patient signed and dated informed consent form at enrollment;
* life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis
Exclusion Criteria:
* absence of venous access available for implant;
* contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
* pregnant patients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04904393
Study Brief:
Protocol Section:
NCT04904393