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

Paracor Ventricular Support System: United States Clinical Investigational Plan

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure, Congestive
• Intervention / Treatment: Device: Placement of the PVSS Implant

Detailed Description

Please refer to brief summary.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham, Division of Cardiovascular Disease
  • Colorado
    • Denver, Colorado, United States, 80262
      • University of Colorado, Health Sciences Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida, Division of Cardiology
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid America Heart Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • BryanLGH Heart Institute
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Heart Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Paracor Medical, Inc

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 10, 2006
• First Submitted That Met QC Criteria: February 10, 2006
• First Posted (Estimate): February 14, 2006

Study Record Updates

• Last Update Posted (Estimate): May 21, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 102.1