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

This study has been terminated.
(Resources unavailable to continue study follow-up.)
Sponsor:
Information provided by (Responsible Party):
Paracor Medical, Inc
ClinicalTrials.gov Identifier:
NCT00291551
First received: February 10, 2006
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
Device: Placement of the PVSS Implant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paracor Ventricular Support System: United States Clinical Investigational Plan

Resource links provided by NLM:


Further study details as provided by Paracor Medical, Inc:

Primary Outcome Measures:
  • Death or Additional Surgical Session at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Implant Success (Number of Participants Successfully Implanted) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    "Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.

  • Change in NYHA Functional Class [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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.

  • Changes in Left Ventricular Diameters [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)

  • Changes in Left Ventricular Volumes [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)

  • Change in Left Ventricular Ejection Fraction [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)

  • Change in Left Ventricular Mass [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)

  • Changes in 6 Minute Walk [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Mean change in 6 minute walk distance (meters) between baseline and 6 months

  • Changes in Cardiopulmonary Tests [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months

  • Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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.

  • Number of Adverse Events [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
    Total adverse events reported prior to study closure

  • Number of Participants Who Died [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
    Total number of patient deaths reported prior to study closure


Enrollment: 39
Study Start Date: January 2005
Study Completion Date: April 2011
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • HeartNet
    • Ventricular support device
    • Ventricular elastic support therapy
Detailed Description:

Please refer to brief summary.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291551

Locations
United States, Alabama
University of Alabama at Birmingham, Division of Cardiovascular Disease
Birmingham, Alabama, United States, 35294
United States, Colorado
University of Colorado, Health Sciences Center
Denver, Colorado, United States, 80262
United States, Florida
University of Florida, Division of Cardiology
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Mid America Heart Institute
Kansas City, Missouri, United States, 64111
United States, Nebraska
BryanLGH Heart Institute
Lincoln, Nebraska, United States, 68506
United States, Ohio
The Ohio State University Heart Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Paracor Medical, Inc
Investigators
Principal Investigator: William T Abraham, MD Ohio State University
  More Information

No publications provided

Responsible Party: Paracor Medical, Inc
ClinicalTrials.gov Identifier: NCT00291551     History of Changes
Other Study ID Numbers: 102.1
Study First Received: February 10, 2006
Results First Received: April 14, 2011
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014