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

NCT00291551 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-05-21

Study results available
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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.

Conditions

  • Heart Failure, Congestive

Interventions

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.

Sponsors & Collaborators

  • Paracor Medical, Inc

    lead INDUSTRY

Principal Investigators

  • William T Abraham, MD · Ohio State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00291551 on ClinicalTrials.gov