Tests an interatrial shunt device in adults with heart failure and reduced heart pumping
Tests a heart shunt device in adults with heart failure with reduced ejection fraction.
Plain-language title generated from the registry record
Registry title: RELIEVE METAB Study
Key facts
- Where
- Düsseldorf, GermanySee the site
Where in Germany
- University Hospital DuesseldorfDüsseldorf, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heinrich-Heine University, Duesseldorf
- Trial code
- NCT07555925
- Record updated
- 29 April 2026
- Original description
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.Read full original descriptionShow less
Interatrial Shunt Device (IASD) Treatment in Symptomatic Heart Failure With Reduced Left Ventricular Ejection Fraction (HFrEF) Alleviates Elevated Myocardial Left Ventricular Pressures, Improves Myocardial Mitochondrial Function and Promotes Regional and Global Myocardial Recovery
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.
Inclusion: 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: Valvular Disease:; Severe, untreated mitral stenosis or aortic stenosis or regurgitation; Mitral repair device <3 months prior to enrollment; Recent Events:; ACS, PCI, Cardiac Surgery (< 3 months prior to enrollment); CAD requiring revascularization; Stroke, TIA, PE, Thrombosis (< 6 months prior to enrollment); 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; Any non-cardiac condition with life expectancy <1 years (e.g., cirrhosis, cancer not in remission, etc.); Hemodynamics: Resting SBP < 90 or > 160 mmHg; Severe PH (PASP >70 mmHg, PVR > 4 Wood Units); Anatomy/Structure:; intracardiac thrombus; Severe RV dysfunction (TAPSE <12 mm or RVFAC ≤25%); LVEDD > 8 cm; Significant ASD or PFO; Subject belongs to a vulnerable population.