Heart failure
Conditions
Interventions
None listed
Sponsors
Occlutech US LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all inclusion criteria: 1) Written informed consent 2) Aged >=18 years 3) Presence of chronic symptomatic HF (NYHA >=class 2) and at least one of the following: a. Prior heart failure hospitalization within 6 months of informed consent, or b. Increased NT-proBNP within 2 months of informed consent according to the following: i. If LVEF = 15mmHg at rest within previous 12 months, or c. LVEDP >=15mmHg at rest within previous 12 months 5) 6MWT distance 100-450 meters 6) Treated with maximally tolerated doses of class I GDMT and class I electrical therapies (CRT and ICD) according to latest applicable guidelines (e.g., AHA or ESC) for at least 2 months prior to informed consent, and a stable (no more than 100% increase or 50% decrease) dose diuretic for at least 1 month prior to informed consent. Note: lack of insurance coverage or affordability is a valid reason not to be treated with a class I agent or device. An attempt to reach maximum dose of GDMT that is not tolerated and followed by successful resumption of the lower stable dose that had been maintained for at least 2 months without clinical instability requires a 1-month waiting period.
Exclusion criteria
Exclusion criteria: Subjects are not eligible for clinical study participation if they meet any of the following exclusion criteria: General Exclusion Criteria 1) Myocardial infarction and/or revascularization with percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to informed consent 2) Surgical or transcatheter valve (aortic, mitral, or tricuspid) repair or replacement within 2 months prior to informed consent 3) Automated implantable cardioverter defibrillator (AICD) placement within 2 months prior to informed consent 4) Resynchronization therapy started within 3 months 5) Major surgery within 3 months prior to informed consent 6) History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding 7) Uncontrolled atrial fibrillation with resting heart rate >110 beats per minute despite medical therapy 8) Advanced heart failure defined as ACC/AHA Stage D heart failure 9) Current or recent Heart Failure hospitalization within 4 weeks 10) Documented history of non-dilated cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease 11) Clinically significant valvular heart disease: a. regurgitation grade >=3+ or b. severe stenosis of mitral or tricuspid valves, or c. moderate or greater stenosis of aortic valves 12) Prior diagnosis of pulmonary hypertension with current treatment with one or more pulmonary hypertension specific drugs (e.g. endothelin receptor antagonists (ERAs), phosphodiesterase inhibitors (PDE 5 Inhibitors) or prostacyclin analogues) 13) Uncontrolled hypertension, Systolic Blood Pressure (SBP) >=160 or Diastolic Blood Pressure (DBP) >=100 mmHg despite medical therapy at the time of screening visit 14) Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure 15) Inadequate vascular access for implantation of shunt, e.g., suboptimal femoral venous access for transseptal catheterization or inferior vena cava (IVC) is not patent 16) Sepsis or other infection(s) requiring systemic antibiotics 17) Chronic kidney disease currently requiring dialysis 18) Allergy or contraindication to aspirin, or clopidogrel and prasugrel and ticagrelor, or heparin and bivalirudin 19) Bleeding disorders (international normalized ratio [INR] >2.0, platelet count <100,000 x 109/L, hemoglobin <10.0 g/dL) 20) Inability to stop oral anticoagulation 4 days before and 4 days after procedure 21) Known clinically significant untreated carotid artery stenosis likely to require intervention, at discretion of investigator 22) Current untreated coronary artery disease with indication for revascularization 23) Contraindication to transesophageal echocardiography (TEE) or intra-cardiac echo (ICE) 24) Right ventricular systolic pressure >= 70 mmHg on Screening TTE 25) Significant Right Ventricular dysfunction demonstrated by: a. Tricuspid Annular Plane Systolic Excursion (TAPSE) <16mm or b. Right Ventricular Fractional Area Change (RVFAC) <=30% 26) Right Atrial Volume Index (RAVI) > 31 mL/m2 27) Left Ventricular End-Diastoli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Efficacy Endpoint is a composite with the following hierarchical testing: • Incidence of and time to Cardiovascular Mortality through 12-24-months • Incidence of and time to heart transplant or left ventricular assist device through 12-24-months • Total rate (first plus recurrent) per patient year of heart failure hospitalization admissions and time-to-first heart failure hospitalization through 12-24-months • Total rate (first plus recurrent) per patient year of heart failure treatment intensification event and time-to-first heart failure treatment intensification event through 12-24 months • Change in baseline KCCQ total summary score at 6-months. The final primary endpoint analysis will occur when the last randomized subject reaches their 12-month follow-up. Data from subjects that have completed any follow-up visits up to and including the 24-month follow-up will be included in the primary endpoint analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| •Clinical Performance, including change from baseline in: o New York Heart Association (NYHA) Class o Kansas City Cardiomyopathy Questionnaire (KCCQ) o Euro Quality of Life 5 Dimension (EQ-5D) o Change in 6-Minute Walk Test (6MWT) • Components of primary efficacy endpoint o Cardiovascular mortality o Heart failure hospitalization rate o Heart failure treatment intensification rate o Heart transplant or LVAD placement • Device Performance: o Device placed in-situ as assessed by investigator o Patency: Evidence of left to right shunt through AFR device as assessed by core lab o Implant embolization and clinically significant device migration (i.e. Serious Adverse Events (SAE)s probably related to device) | — |
Countries
Netherlands
Outcome results
None listed