Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Heart Failure With Preserved Ejection Fraction
• Age: Between 40 Year(s) - 100 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Chronic symptomatic heart failure (HF) documented by each of the following:
  • History of HF for at least 6 months prior to enrollment AND
  • Symptoms of HF requiring current treatment with diuretics for = 30 days
  2. Ongoing stable guideline directed medical therapy (GDMT) heart failure management and management of comorbidities. Stable defined as no significant changes (> 100% increase or 50% decrease), for a minimum of 4 weeks prior to enrollment. Diuretic dose changes are to be stable for a minimum of 2 weeks prior to enrollment. Stable GDMT HF management includes a minimum period of 4 weeks post hospitalization for any cause, including treatment with IV diuretics
  3. Patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent
  4. Patient is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams

  
  

You may not be eligible for this study if the following are true:

• 1. Advanced heart failure (HF) documented in the medical history, defined as one or more of the following
  • Stage D Heart Failure
  • Patient is on the cardiac transplant waiting list
  • Inotropic infusion (continuous or intermittent) within 6 months of screening visit
  2. Clinically significant untreated carotid artery stenosis documented in the medical history that is likely to require intervention
  3. Clinically significant un-revascularized coronary artery disease (CAD) documented in the medical history that is likely to require intervention, defined as epicardial coronary artery stenosis associated with angina or other evidence of coronary ischemia
  4. Medical history of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), pulmonary embolism (PE) or other peripheral arterial embolus within 12 months of enrollment
  5. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy such as hemochromatosis or sarcoidosis
  6. Medical history of one or more of the following cardiac procedures:
  • Myocardial infarction (MI) and/or percutaneous coronary intervention (PCI) within 3 months of enrollment
  • Coronary artery bypass graft (CABG) within 3 months of enrollment
  • Surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) within 6 months of enrollment
  • Surgical mitral valve repair/surgical mitral valve replacement (SMVR) or mitral valve transcatheter edge-to-edge repair (TEER) or transcatheter mitral valve replacement (TMVR) within 6 months of enrollment
  7. Medical history of mechanical cardiac support (such as intra-aortic balloon pump [IABP] or Impella) within 6 months of enrollment, except for short (peri-procedural) support during PCI or cardiac surgery
  8. Medical history of any implanted pacemaker, defibrillator, or leads OR subject is anticipated to require either device within 12 months of enrollment
  9. Medical history of cardiac ablation procedure (either for atrial or ventricular arrhythmias) within 3 months of enrollment
  10. Anticipated need for another trans-septal procedure within 3 months of the study procedure (investigator determination)
  11. Chronic pulmonary disease documented in the medical history, defined as one or more of the following:
  • Home oxygen use dependent
  • Hospitalization for treatment of chronic pulmonary disease within 12 months of enrollment
  • Significant chronic pulmonary disease
  • If severe chronic obstructive pulmonary disease (COPD) is documented in the medical history, a spirometry test is to be performed
  12. Severe obstructive sleep apnea not treated adequately by continuous positive airway pressure (CPAP) or other measures, documented in the medical history
  13. Subject is currently requiring dialysis OR subjects is anticipated to begin dialysis within 12 months of enrollment
  14. Women who are pregnant or plan to become pregnant during the study
  15. Subject life expectancy < 12 months
  16. Subject is currently participating in an investigational drug or device study that would interfere with the conduct or results of this study
      
      Note: trials requiring extended follow-up for products that were investigational but have since become commercial are not considered investigational.
  17. Subject has known or suspected contraindication to dual antiplatelet therapy (DAPT) or oral anticoagulant, or has coagulopathy, documented in the medical history
  18. Current use of immunosuppressive therapy (including prednisone > 10 mg daily or equivalent) documented in the medical history
  19. Moderate or worse right heart dysfunction documented in the medical history
  20. Patients with an existing or surgically closed atrial septal defect (ASD)
  21. Active infection requiring antibiotics at the time of the study procedure