Heart Failure With Reduced Ejection Fraction (HFrEF)
Investigational drug(s) / intervention(s)
cardiac MRIFunctional Testing
cardiac MRI: Cardiac Imaging: Multiparametric cardiac MRI (cMRI) and Phosphorus-31 Magnetic Resonance Spectroscopy (³¹P-MRS) at rest and during cycle ergometry to evaluate ventricular volumes, pressures, and myocardial energy efficiency
Functional Testing: Cardiopulmonary exercise testing (CPET) to quantify functional capacity via VO2 max and standardized symptom assessment in the heart failure unit.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Ischemic or non-ischemic cardiomyopathy with LVEF ≤ 40%
2. Patient is eligible and scheduled to receive the Ventura IASD as per the current IFU.
3. Symptoms: NYHA Class III
4. Stability: Chronic heart failure for ≥ 6 months on stable, and at least 3 months on guideline-directed medical therapy (GDMT)
5. Biomarkers: NTproBNP ≥ 1,200 pg/ml
6. Age 18 years or older
7. 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:
1. Hemodynamics: Resting SBP \< 90 or \> 160 mmHg
2. Severe PH (PASP \>70 mmHg, PVR \> 4 Wood Units)
3. Anatomy/Structure:
* intracardiac thrombus
* Severe RV dysfunction (TAPSE \<12 mm or RVFAC ≤25%)
* LVEDD \> 8 cm
* Significant ASD or PFO
4. Valvular Disease:
* Severe, untreated mitral stenosis or aortic stenosis or regurgitation
* Mitral repair device \<3 months prior to enrollment
5. Recent Events:
* ACS, PCI, Cardiac Surgery (\< 3 months prior to enrollment)
* CAD requiring revascularization
* Stroke, TIA, PE, Thrombosis (\< 6 months prior to enrollment)
6. Issues undergoing MRI: e.g non-compatible implant, claustrophobia, or physically not suitable for MRI
7. 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
8. 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
9. Any non-cardiac condition with life expectancy \<1 years (e.g., cirrhosis, cancer not in remission, etc.)
10. Subject belongs to a vulnerable population
Primary outcome measure(s)
Reverse LV remodeling — Baseline to 12 months The primary endpoint is to achieve reverse remodeling detected by gold standard cMRI, comparing left-ventricular end-diastolic volume (LVEDV).
Trial sites (1)
Facility
City
Region
Status
University Hospital Duesseldorf
Düsseldorf
North Rhine-Westphalia
More Heinrich-Heine University, Duesseldorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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