NCT07555925Not yet recruiting
RELIEVE METAB Study
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Diseases
- Heart failure
- NCT number
- NCT07555925
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Jun 2026 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- Any non-cardiac condition with life expectancy \<1 years (e.g., cirrhosis, cancer not in remission, etc.)
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Duesseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.