RELIEVE METAB Study (NCT07555925) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RELIEVE METAB Study
Germany15 participantsStarted 2026-06-01
Plain-language summary
This prospective, single-center post-market-follow-up study aims to fill knowledge gaps by combining advanced cardiac MRI/MRS with systemic mitochondrial assays and exercise testing to characterize the energetic and functional impact of IASD therapy in HFrEF patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ischemic or non-ischemic cardiomyopathy with LVEF ≤ 40%
✓. Patient is eligible and scheduled to receive the Ventura IASD as per the current IFU.
✓. Symptoms: NYHA Class III
✓. Stability: Chronic heart failure for ≥ 6 months on stable, and at least 3 months on guideline-directed medical therapy (GDMT)
✓. Biomarkers: NTproBNP ≥ 1,200 pg/ml
✓. Age 18 years or older
✓. Subject has signed informed consent form and is willing and able to attend all follow-up visits and is physically capable of performing all tests.
Exclusion criteria
✕. Hemodynamics: Resting SBP \< 90 or \> 160 mmHg
✕. Issues undergoing MRI: e.g non-compatible implant, claustrophobia, or physically not suitable for MRI
✕. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
✕. Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits