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Safety and Efficacy Study of the BioVentrix PliCath HF System

NCT01568164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-03-11

No results posted yet for this study

Summary

The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.

Conditions

Interventions

DEVICE

PliCath HF System

This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix PliCath HF System for left ventricular volume restoration in patients with ischemic cardiomyopathy.

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • CDI Centro Diagnostico Italiano

    collaborator UNKNOWN

  • Advance Research Associates

    collaborator OTHER

  • BioVentrix

    lead INDUSTRY

Principal Investigators

  • Lon Annest, MD · Chief Medical Officer, BioVentrix

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Austria
  • Czechia
  • France
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Spain
  • United Kingdom

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 NCT01568164 on ClinicalTrials.gov