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Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

NCT04890821 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-11-30

No results posted yet for this study

Summary

An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).

Conditions

  • Tricuspid Regurgitation Functional

Interventions

DEVICE

CI Percutaneous Ring Annuloplasty System

Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.

Sponsors & Collaborators

  • Cardiac Implants LLC

    lead INDUSTRY

Principal Investigators

  • Nodar Kipshidze, MPH · Cardiac Implants LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-08-31
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

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 NCT04890821 on ClinicalTrials.gov