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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT06580392
Eligibility Criteria:
Inclusion Criteria:
1. Adults (≥18 years) diagnosed with symptomatic heart failure
2. Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%
\- Historical LVEF assessed up to 6 months prior to consent by any modality can be used if available
3. Patients can have an active concomitant CRT device already - implanted provided the following criteria:
* CRT device has been implanted \>1 year
* Patients are functional class NYHA III-IV
Exclusion Criteria:
1. Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications.
2. Patients with a QMS score \>5
3. eGFR \<15
4. Patients with a concomitant CRT device that has already been implanted and deemed to be a responder
5. Patients with class I indication for a concomitant CRT device
6. Patients with significant comorbidities or conditions that may interfere with the study assessments
7. Patients with contraindications to CCM therapy or unable to undergo implantation
8. Severe stenotic valve disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06580392
Study Brief:
Protocol Section:
NCT06580392