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NCT04433065 · ClinicalTrials.gov registry record · NA

TTVR Early Feasibility Study

A NA study of Tricuspid Regurgitation, sponsored by Medtronic Cardiovascular.

Recruiting
Registry status
NA
Development phase
150
Enrollment target
20
Study locations

NCT04433065 is a NA study of Tricuspid Regurgitation that is actively recruiting participants, run by Medtronic Cardiovascular. The registered enrollment target is 150 participants, below the 527-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT04433065, a NA study of Tricuspid Regurgitation, is actively recruiting participants, sponsored by Medtronic Cardiovascular.

RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
20
Study locations

Study Summary

The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Conditions Studied

Interventions

  • DEVICE Intrepid™ TTVR System

Study Locations (20)

New York

  • The Mount Sinai Hospital - New York
  • New York-Presbyterian Hospital Columbia University Medical Center - New York
  • Montefiore Medical Center - The Bronx

Ohio

  • The Christ Hospital - Cincinnati
  • University Hospitals Cleveland Medical Center - Cleveland
  • OhioHealth Riverside Methodist Hospital - Columbus

California

  • Cedars Sinai Medical Center - Los Angeles
  • California Pacific Medical Center - San Francisco

Michigan

  • University of Michigan Health System - University Hospital - Ann Arbor
  • Corewell Health - Grand Rapids

Alabama

  • University of Alabama at Birmingham (UAB) Hospital - Birmingham

Arizona

  • Abrazo Arizona Heart Hospital - Phoenix

Connecticut

  • Hartford Hospital - Hartford

Georgia

  • Emory University Hospital Midtown - Atlanta

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2020-10-20
Est. Completion 2031-07-30
Phase NA

Sponsor

Medtronic Cardiovascular

44 total trials

What the Registry Record Tells You About NCT04433065

The ClinicalTrials.gov registry entry for NCT04433065 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 527-participant average among 17 other Tricuspid Regurgitation trials with a reported enrollment target (72% lower). The listed sponsor is Medtronic Cardiovascular, which has 44 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tricuspid Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Intrepid™ TTVR System is the first listed.

NCT04433065 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, Ohio, California.

Frequently Asked Questions

What is clinical trial NCT04433065 about?

NCT04433065 is a clinical study titled "TTVR Early Feasibility Study". The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

What is the current status of trial NCT04433065?

This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-10-20. Estimated completion is 2031-07-30.

What conditions does trial NCT04433065 study?

This clinical trial studies the following conditions: Tricuspid Regurgitation.

What interventions are being tested in trial NCT04433065?

The interventions under investigation include: Intrepid™ TTVR System (DEVICE).

Who is sponsoring clinical trial NCT04433065?

This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04433065 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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