NCT00291551

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2 months until next milestone

Results Posted

Study results publicly available

June 10, 2011

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

February 10, 2006

Results QC Date

April 14, 2011

Last Update Submit

May 14, 2012

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • Death or Additional Surgical Session at 6 Months

    6 months

Secondary Outcomes (11)

  • Implant Success (Number of Participants Successfully Implanted)

    1 day

  • Change in NYHA Functional Class

    Baseline to 6 months

  • Changes in Left Ventricular Diameters

    Baseline to 6 months

  • Changes in Left Ventricular Volumes

    Baseline to 6 months

  • Change in Left Ventricular Ejection Fraction

    Baseline to 6 months

  • +6 more secondary outcomes

Interventions

Placement of the PVSS ImplantDEVICE

Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.

Also known as: HeartNet, Ventricular support device, Ventricular elastic support therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA functional class II or III
  • Best medical therapy
  • Ejection fraction \<= 35%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Alabama at Birmingham, Division of Cardiovascular Disease

Birmingham, Alabama, 35294, United States

Location

University of Colorado, Health Sciences Center

Denver, Colorado, 80262, United States

Location

University of Florida, Division of Cardiology

Gainesville, Florida, 32610, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

BryanLGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

The Ohio State University Heart Center

Columbus, Ohio, 43210, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

Insufficient resources to continue study follow-up.

Results Point of Contact

Title
Michael Kolber, General Manager, VP, Regulatory Affairs
Organization
Paracor Medical, Inc.
info@paracor.com
408-734-6000

Study Officials

  • William T Abraham, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 14, 2006

Study Start

January 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2011

Last Updated

May 21, 2012

Results First Posted

June 10, 2011

Record last verified: 2012-05

Locations

US(12)