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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
History of Changes
Results First Received: April 14, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure, Congestive
Intervention: Device: Placement of the PVSS Implant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12 investigational sites enrolled 39 subjects between January 2005 and October 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Non-randomized, Single- Arm, Treatment Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.

Participant Flow:   Overall Study
    Non-randomized, Single- Arm, Treatment  
STARTED     39  
COMPLETED     26  
NOT COMPLETED     13  
Death                 7  
Withdrawal by Subject                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Non-randomized, Single- Arm, Treatment Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.

Baseline Measures
    Non-randomized, Single- Arm, Treatment  
Number of Participants  
[units: participants]
 		  39  
Age  
[units: years]
Mean ± Standard Deviation 		  53  ± 11.0  
Gender  
[units: participants]
 		 
Female     3  
Male     36  
Race (NIH/OMB) [1]
[units: participants]
 		 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     35  
More than one race     0  
Unknown or Not Reported     1  
Etiology  
[units: participants]
 		 
Ischemic     8  
Non-ischemic     31  
Duration of heart failure  
[units: years]
Mean ± Standard Deviation 		  6.9  ± 4.7  
[1] Measured as Caucasian, Black, of African heritage, and Hispanic



  Outcome Measures
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1.  Primary:   Death or Additional Surgical Session at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Implant Success (Number of Participants Successfully Implanted)   [ Time Frame: 1 day ]
  Show Outcome Measure 2

3.  Secondary:   Change in NYHA Functional Class   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 3

4.  Secondary:   Changes in Left Ventricular Diameters   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 4

5.  Secondary:   Changes in Left Ventricular Volumes   [ Time Frame: Baseline to 6 months ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Changes in Left Ventricular Volumes
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
per protocol

Reporting Groups
  Description
Non-randomized, Single Arm, Treatment No text entered.

Measured Values
    Non-randomized, Single Arm, Treatment  
Number of Participants Analyzed  
[units: participants]
 		  35  
Changes in Left Ventricular Volumes  
[units: milliliters]
Mean ± Standard Deviation 		 
LVEDV (ml)     -31.6  ± 65.2  
LVESV (ml)     -29.6  ± 61.6  

No statistical analysis provided for Changes in Left Ventricular Volumes



6.  Secondary:   Change in Left Ventricular Ejection Fraction   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 6

7.  Secondary:   Change in Left Ventricular Mass   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 7

8.  Secondary:   Changes in 6 Minute Walk   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 8

9.  Secondary:   Changes in Cardiopulmonary Tests   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 9

10.  Secondary:   Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score   [ Time Frame: Baseline to 6 months ]
  Show Outcome Measure 10

11.  Secondary:   Number of Adverse Events   [ Time Frame: Study duration ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants Who Died   [ Time Frame: Study duration ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Insufficient resources to continue study follow-up.  


Results Point of Contact:  
Name/Title: Michael Kolber, General Manager, VP, Regulatory Affairs
Organization: Paracor Medical, Inc.
phone: 408-734-6000
e-mail: info@paracor.com


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