Paracor Ventricular Support System (PVSS) for Patients With Heart Failure

Study Overview
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Brief Summary
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This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles. No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.

Detailed Description
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Please refer to brief summary.

Official Title
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Paracor Ventricular Support System: United States Clinical Investigational Plan

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: Placement of the PVSS Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NYHA functional class II or III Best medical therapy Ejection fraction <= 35% Exclusion Criteria: Heart measurements too large or small for implant sizes Intra-cardiac thrombus Restrictive cardiomyopathy Not a candidate for sternotomy Expected adhesions Previous coronary artery bypass graft (CABG) Active infection Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months Myocardial infarction (MI) within 1 month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Placement of the PVSS Implant|Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or Additional Surgical Session at 6 Months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Success (Number of Participants Successfully Implanted) | Implant success refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. | 1 day | 
| Change in NYHA Functional Class | Change in NYHA functional class between baseline and 6 months. Maintained means the participant's functional class remains the same as baseline. Improved means the participant's functional class has improved (become lower in number) by at least one class. Worsened means the participatn's functional class has deteriorated (become higher in number) by at least one class. | Baseline to 6 months | 
| Changes in Left Ventricular Diameters | Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements) | Baseline to 6 months | 
| Changes in Left Ventricular Volumes | Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements) | Baseline to 6 months | 
| Change in Left Ventricular Ejection Fraction | Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements) | Baseline to 6 months | 
| Change in Left Ventricular Mass | Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements) | Baseline to 6 months | 
| Changes in 6 Minute Walk | Mean change in 6 minute walk distance (meters) between baseline and 6 months | Baseline to 6 months | 
| Changes in Cardiopulmonary Tests | Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months | Baseline to 6 months | 
| Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score | The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death. | Baseline to 6 months | 
| Number of Adverse Events | Total adverse events reported prior to study closure | Study duration | 
| Number of Participants Who Died | Total number of patient deaths reported prior to study closure | Study duration |