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BioVentrix Revivent TC™ System Clinical Study

NCT02931240 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-08-22

No results posted yet for this study

Summary

A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.

Conditions

  • Ventricular Dysfunction, Left

Interventions

DEVICE

Revivent TC

Treatment of LV scar

Sponsors & Collaborators

  • BioVentrix

    lead INDUSTRY

Principal Investigators

  • Andrew S Wechsler, MD · Drexel University College of Medicine

  • Gregg W Stone, MD · Icahn School of Medicine at Mount Sinai

  • Jerry D Estep, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2023-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States
  • Czechia
  • Greece
  • United Kingdom

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 NCT02931240 on ClinicalTrials.gov