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VisONE Heart Failure Study: Pilot

NCT03484780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-05-20

No results posted yet for this study

Summary

The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system for 12 months.

Conditions

  • Heart Failure With Reduced Ejection Fraction, HFrEF

Interventions

DEVICE

VisONE ADS

VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation

Sponsors & Collaborators

  • Clinical Accelerator

    collaborator INDUSTRY

  • University of Glasgow

    collaborator OTHER

  • University Hospital, Zürich

    collaborator OTHER

  • Stiftung für Herz-und Kreislaufkrankheiten

    collaborator UNKNOWN

  • VisCardia Inc.

    lead INDUSTRY

Principal Investigators

  • Vitaly Demyanchuk, M.D. Ph.D. · Kyiv City Heart Center

  • Rudenko Vladimirovich, M.D. · Amosov National Institute of Cardiovascular Surgery

  • Tamaz Shaburishvil, M.D. · Tbilisi Heart and Vascular Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-25
Primary Completion
2019-12-12
Completion
2019-12-12

Countries

  • Georgia
  • Ukraine

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 NCT03484780 on ClinicalTrials.gov