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Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial

NCT00382863 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2012-07-13

Study results available
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Summary

The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm (Treatment group) show statistically significant improvement compared to patients in the optimal medical and device therapy alone arm (Control group) after 6 months of follow-up.

Conditions

Interventions

DEVICE

HeartNet Ventricular Support System

The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.

DRUG

Optimal Medical/Device Therapy

Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated.

Sponsors & Collaborators

  • Paracor Medical, Inc

    lead INDUSTRY

Principal Investigators

  • William T. Abraham, MD · Chief, Division of Cardiovascular Medicine, The Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-05-31
Completion
2012-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00382863 on ClinicalTrials.gov