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

Primary Purpose

Heart Failure, Congestive

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placement of the PVSS Implant
Sponsored by
Paracor Medical, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham, Division of Cardiovascular Disease
  • University of Colorado, Health Sciences Center
  • University of Florida, Division of Cardiology
  • Emory University Hospital
  • University of Maryland Medical Center
  • The Johns Hopkins Hospital
  • Minneapolis VA Medical Center
  • Mid America Heart Institute
  • BryanLGH Heart Institute
  • The Ohio State University Heart Center
  • Penn State Milton S. Hershey Medical Center
  • The Methodist Hospital

Outcomes

Primary Outcome Measures

Death or Additional Surgical Session at 6 Months

Secondary Outcome Measures

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.
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.
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)
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)
Change in Left Ventricular Ejection Fraction
Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)
Change in Left Ventricular Mass
Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
Changes in 6 Minute Walk
Mean change in 6 minute walk distance (meters) between baseline and 6 months
Changes in Cardiopulmonary Tests
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
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
Total adverse events reported prior to study closure
Number of Participants Who Died
Total number of patient deaths reported prior to study closure

Full Information

First Posted
February 10, 2006
Last Updated
May 14, 2012
Sponsor
Paracor Medical, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00291551
Brief Title
Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
Acronym
PEERLESS-HF
Official Title
Paracor Ventricular Support System: United States Clinical Investigational Plan
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Resources unavailable to continue study follow-up.
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paracor Medical, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Please refer to brief summary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Placement of the PVSS Implant
Other Intervention Name(s)
HeartNet, Ventricular support device, Ventricular elastic support therapy
Intervention Description
Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.
Primary Outcome Measure Information:
Title
Death or Additional Surgical Session at 6 Months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Implant Success (Number of Participants Successfully Implanted)
Description
"Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.
Time Frame
1 day
Title
Change in NYHA Functional Class
Description
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.
Time Frame
Baseline to 6 months
Title
Changes in Left Ventricular Diameters
Description
Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)
Time Frame
Baseline to 6 months
Title
Changes in Left Ventricular Volumes
Description
Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)
Time Frame
Baseline to 6 months
Title
Change in Left Ventricular Ejection Fraction
Description
Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)
Time Frame
Baseline to 6 months
Title
Change in Left Ventricular Mass
Description
Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
Time Frame
Baseline to 6 months
Title
Changes in 6 Minute Walk
Description
Mean change in 6 minute walk distance (meters) between baseline and 6 months
Time Frame
Baseline to 6 months
Title
Changes in Cardiopulmonary Tests
Description
Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months
Time Frame
Baseline to 6 months
Title
Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score
Description
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.
Time Frame
Baseline to 6 months
Title
Number of Adverse Events
Description
Total adverse events reported prior to study closure
Time Frame
Study duration
Title
Number of Participants Who Died
Description
Total number of patient deaths reported prior to study closure
Time Frame
Study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William T Abraham, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham, Division of Cardiovascular Disease
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Colorado, Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Florida, Division of Cardiology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Mid America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
BryanLGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
The Ohio State University Heart Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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