Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

TTVR Early Feasibility Study

NCT04433065 · View on ClinicalTrials.gov ↗

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

49 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04433065

The ClinicalTrials.gov registry entry for NCT04433065 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04433065 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04433065?

The interventions under investigation include: Intrepid™ TTVR System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04433065?

This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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