Health Trials

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Hemodynamics: Resting SBP < 90 or > 160 mmHg

Severe PH (PASP >70 mmHg, PVR > 4 Wood Units)

intracardiac thrombus

Severe RV dysfunction (TAPSE <12 mm or RVFAC ≤25%)

Trial design

Treatments tested in this trial

  • cardiac MRI
  • Functional Testing

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

1
University Hospital Duesseldorf40225, DüsseldorfNorth Rhine-Westphalia, Germany

Sponsors and collaborators

Heinrich-Heine University, Duesseldorf

Lead sponsor

Source ClinicalTrials.gov