Safety and Efficacy Study of the BioVentrix PliCath HF System

Study Overview
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Brief Summary
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The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.

Detailed Description
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Congestive heart failure is the epidemic of cardiovascular disease (Eugene Braunwald, NEJM 1997), yet there is no cure. The American Heart Association reports the nearly five million Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart failure; it is the number one cost-item for Medicare, comprising 6% of its total expenditures. BioVentrix has developed the PliCath heart failure system, which is used to place permanent cardiac implants into the heart for the purpose of excluding scar, reconfiguring abnormal cardiac geometry that is causing dysfunction, by excluding an abnormal portion of the ventricular wall. Conceptually, the final configuration in SVR can be achieved by placing these implants. The procedure called PliCath Epicardial Catheter-based Ventricular Restoration System (ECVR) is designed for left ventricular volume reduction in patients with heart failure in a magnitude similar to that of the predicate surgical procedure, but much less invasively. The PliCath HF System utilizes anchors that are implanted into the scarred portion of the heart, which when deployed, exclude some of the scar similar to what is excluded by cinching the purse string suture with the patch, rendering the ventricle smaller, and is employed in a surgical setting, with and without the use of cardiopulmonary bypass. The PliCath HF System has anchors (implants) that are deployed using fluoroscopic imaging.

Official Title
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Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy

Conditions
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Heart Failure

Intervention / Treatment
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* Device: PliCath HF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age 18 - 80; Left Ventricular Ejection Fraction (LVEF) >15% and ≤ 45%; NYHA FC II-IV; Left Ventricular End Systolic Volume (LVESVI) ≥60 cc/m² but ≤ 120 cc/ m² Contiguous acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) regions of the left ventricle as evidenced by a CMR or CT; Maintained standard medical management for at least 90 days, and at stable target (or maximum tolerated) dosages; Willing and competent to complete informed consent; Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by CMR or CT; Agree to required follow-up visits Exclusion Criteria Calcified ventricular wall in the area of intended scar exclusion as verified by echocardiography or equivalent; Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent; Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment; Significant diastolic dysfunction, defined as a pseudo-normal Doppler filling pattern with E/A ratio > 2; Thin walled, paradoxically moving septal scar that would preclude successful support of the anchor pairs as evidenced by CMR; Cardiac valve disease which, in the opinion of the investigator, will require surgery; Intolerance or unwillingness to take anti-coagulation medication; Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement; Pulmonary Arterial Pressure > 60 mm Hg via echo; Myocardial Infarction within 90 days prior to enrollment; Previous CVA or TIA which resulted, in the opinion of the investigator, in a significant residual neurological deficit; Aorto iliac disease that would preclude fem-fem bypass. Previous right neck surgery, previous pericardiotomy, previous left chest surgery; Co-morbid disease process with life expectancy of less than one year; Patients with lung, kidney and/or liver transplant; Chronic renal failure with a serum creatinine >2 mg/dL; Pregnant or planning to become pregnant during the study; Enrolled in any concurrent study other than observational.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Treatment<br>Treatment with the investigational device. | Device: PliCath HF System<br>* This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix PliCath HF System for left ventricular volume restoration in patients with ischemic cardiomyopathy.<br>* Other names: Surgical/Left Ventricular Reconstruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - Overall rate of serious adverse events. | An assessment of the overall rate of serious adverse events (SAEs) at 1 year and 2 years as adjudicated by the Data Monitoring Committee (DMC). | 24 Months | 
| Primary Efficacy Endpoint - Reduction in LV Volume | An assessment of measurable decrease in LV volume by either an echo or a CMR at 6 months, 1 year and 2 years. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects. | The secondary safety endpoint will be an assessment of the overall rate of serious adverse device effects (SADEs) through 2 years as adjudicated by the DMC. | 24 Months post operatively | 
| Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction | Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI. | 24 Months | 
| Secondary Efficacy Endpoint: Hospital readmission for HF | Hospital readmission for HF including surgical intervention such as Ventricular Assist Device, Cardiac Resynchronization Therapy, Intra-Aortic Balloon Pump, or transplant; | 24 Months | 
| Secondary Efficacy Endpoint: Clinical utility | Change in NYHA Class, Change in a standardized 6-minute corridor walk test; Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire. | 24 Months | 
| Secondary Efficacy Endpoint: NT-proBNP | Change in NT-proBNP levels | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epicardial Catheter-based Restoration, Surgical/Left Ventricular Reconstruction, Ventricular Remodeling, Dor