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First in Human Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation

NCT03700918 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-11-12

No results posted yet for this study

Summary

The DaVingi™ System is a percutaneous trans-catheter device delivered using right heart catheterization through the right internal jugular vein. The DaVingi™ System is designed for performing ring annuloplasty by using a Ring Delivery System to place a complete, flexible fabric ring around the annulus of the atrial side of the tricuspid valve. Fluoroscopy and echocardiography are used to monitor the ring placement procedure.

Conditions

  • Functional Tricuspid Regurgitation (TR)

Interventions

DEVICE

DaVingiTR System

DaVingiTR Tricuspid valve annuloplasty repair device

Sponsors & Collaborators

  • Cardiac Implants LLC

    lead INDUSTRY

Principal Investigators

  • Nodar Kipshidze, MPH · Cardiac Implants LLC

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-11
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Czechia
  • France
  • Israel

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 NCT03700918 on ClinicalTrials.gov