Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Heart Failure Solutions, Heart Failure with Preserved Ejection Fraction, PeriCut, Pericardiotomy
Brief summary
The PeriCut early feasibility study will evaluate the safety and feasibility of successfully performing a minimally invasive pericardiotomy in patients with heart failure with preserved ejection fraction using the PeriCut Catheter System.
Detailed description
The PeriCut EFS is a non-randomized, open label, multi-site study testing a new minimally invasive pericardiotomy device for the treatment of heart failure with preserved ejection fraction (HFpEF).
Interventions
DEVICEPeriCut Catheter System performs minimally invasive pericardiotomy
The PeriCut Catheter System will incise the pericardium to reduce filling pressures of the heart.
Sponsors
Mayo Clinic
Heart Failure Solutions, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 30 years * Symptoms of severe dyspnea (NYHA Class III-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea * Ejection fraction of ≥50%, determined on most recent imaging study within the preceding 2 years (730 days), with no change in clinical status, suggesting potential for deterioration in systolic function. * Documentation history of at least one of the following: Any previous hospitalization for HF (\>30 days prior to enrollment) with radiographic evidence of pulmonary congestion (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) or Elevated NT-proBNP (\>300 pg/ml or \>600 pg/ml if in atrial fibrillation) or Echocardiographic evidence of diastolic dysfunction/elevated filling pressures manifested by medial E/e' ratio ≥15 and/or left atrial enlargement and chronic treatment with a diuretic for signs or symptoms of heart failure or Historical catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25), prior to consent. * Catheterization documented elevated filling pressures at rest (PCWP ≥15 or LVEDP ≥18) or with exercise (PCWP ≥25) during the screening/baseline visit (after consent) * Ambulatory with ability to complete 6-minute walk and cardiopulmonary exercise test (not wheelchair / scooter dependent)
Exclusion criteria
* Recent (\< 30 days) hospitalization for heart failure * Left (\> 6 cm) ventricular dilation noted on cardiac imaging study (echocardiography or MRI) within 6 months prior to enrollment. * Any hemoglobin (Hgb) \< 8.0 g/dl within 30 days prior to enrollment * Any GFR \< 20 ml/min/1.73 m2 within 30 days prior to enrollment * Significant alternative cause of dyspnea such as severe chronic obstructive pulmonary disease or ischemia that is a primary contributor to symptoms, in the opinion of the Investigator. * Myocardial infarction (MI), unstable angina, catheter ablation for atrial fibrillation, biventricular pacing device implant, or percutaneous coronary intervention (PCI) within 90 days prior to enrollment * Any prior cardiac surgery * Documented stroke, CVA, TIA, deep vein thrombosis, pulmonary emboli, or suspected neurological event within 180 days prior to enrollment * Diagnosis of obstructive hypertrophic cardiomyopathy * Known infiltrative cardiomyopathy (e.g., amyloid) * Known pericardial disease (constriction, pericarditis, tamponade) * Known allergy or sensitivity to contrast media that cannot be adequately pre-treated prior to the procedure. * Active myocarditis * Significant congenital anomaly, anatomic, or comorbid medical problem that, in the opinion of the Investigator, would preclude enrollment in the study. Active collagen vascular disease * Significant valvular heart disease (greater than mild stenosis or greater than moderate regurgitant lesions) * Acute or chronic severe liver disease, as evidenced by any of the following: encephalopathy, variceal bleeding, INR \> 1.7 in the absence of anticoagulation treatment. * Untreated severe obstructive sleep apnea (if known) * Implantation or planned implantation of any left atrial shunts or implantable devices used to treat heart failure. * Terminal illness (other than HF) with expected survival of less than 1 year * Enrollment or planned enrollment in another therapeutic clinical trial in the next 6 months. * Inability to comply with planned study procedures or follow-up requirements, including cardiac MRI (e.g., claustrophobia or absolute contraindication to MRI) * Women who are currently pregnant, plan to become pregnant, or are currently breastfeeding. * Intolerance or contraindication to colchicine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Safety | 30 day follow up | Characterize the incidence of serious device and procedure related safety events at 30 days post procedure |
| Assessment of Acute Procedural Success | 30 day follow up | Characterize the rate of acute treatment success of the PeriCut Catheter System to complete the pericardiotomy procedure |
Countries
United States
Contacts
Primary ContactMark Strong
Outcome results
None listed