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Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity

NCT00326690 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-01-26

No results posted yet for this study

Summary

The purpose of the present prospective, randomized study is to investigate the clinical effectiveness of standardized left ventricular reconstruction surgery (LVR). In order to standardize the procedure, the operation will be performed with the Blue Egg, manufactured by BioVentrix, a subsidiary of CHF Technologies, Inc.

Conditions

Interventions

DEVICE

Blue Egg Device

Sponsors & Collaborators

  • BioVentrix

    lead INDUSTRY

Principal Investigators

  • Robert R. Lazzara, MD · St. Joseph's Hospital

  • Ulrich Jorde, MD · New York College of Medicine

  • Francis Pagani, MD · University of Michigan

  • James D. Bergin, MD · University of Virginia College of Medicine

  • Howard J Eisen, MD · Drexel University College of Medicine

  • Ernst Schwarz, MD · Cedar Sinai Department of Cardiothoracic Surgery

  • Volkmar Falk, MD · Heart Center Leipzig

  • Mariell Jessup, MD · University of Pennsylvania

  • Erika Feller, MD · University of Maryland College of Medicine

  • Rosemary Peterson, MD · St. Joseph's Hospital - Tacoma, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Germany

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 NCT00326690 on ClinicalTrials.gov