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An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001

NCT02226679 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-08-27

No results posted yet for this study

Summary

The objective of this extension study is to evaluate the safety and potential beneficial effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a dilated cardiomyopathy. The results of this study will provide confirmatory evidence of the long-term safety and effectiveness of the Algisyl-LVR in patients with established heart failure.

Conditions

Interventions

DEVICE

Algisyl-LVR

Algisyl-LVR™ device (implants) administered during a surgical procedure

Sponsors & Collaborators

  • LoneStar Heart, Inc.

    lead INDUSTRY

Principal Investigators

  • Ionel Droc, MD · Emergency Clinic Center for The Army For the Cardiovascular Diseases

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Italy
  • Romania

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 NCT02226679 on ClinicalTrials.gov