All > Tricuspid Regurgitation

Intrepid™ TTVR System for Tricuspid Regurgitation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Aurora Saint Luke's Medical, Milwaukee, WITricuspid RegurgitationIntrepid™ TTVR System - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new, less invasive way to replace a failing tricuspid valve.

Eligible Conditions
  • Tricuspid Regurgitation

Treatment Effectiveness

Effectiveness Progress

1 of 3

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ommitence of defibrillation testing

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Through 30 days post-procedure

During Procedure
Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
Through 30 days post-procedure
Change in NYHA Class from baseline
Change in TR Grade from baseline
Rate of implant or delivery related serious adverse events
Rate of no significant TV stenosis

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
CorMatrix Cor TRICUSPID ECM Valve
3
Licart™ (diclofenac epolamine) topical system
1
ommitence of defibrillation testing

Trial Design

1 Treatment Group

Primary Cohort
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Intrepid™ TTVR System · No Placebo Group · N/A

Primary Cohort
Device
Experimental Group · 1 Intervention: Intrepid™ TTVR System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 30 days post-procedure

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
74 Previous Clinical Trials
36,451 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your heart team has determined that the risk of mortality during tricuspid valve surgery is too high for you.
References

Frequently Asked Questions

To what extent is enrollment in this research endeavor being facilitated?

"To begin the study, 15 eligible participants are necessary. Medtronic Cardiovascular will be managing the experiment from a variety of locations, such as Aurora Saint Luke's Medical in Milwaukee and Abrazo Arizona Heart Hospital in Phoenix." - Anonymous Online Contributor

Unverified Answer

In which areas can participants access this trial?

"Patients may find enrollment opportunities at 15 different sites, including Aurora Saint Luke's Medical in Milwaukee, Abrazo Arizona Heart Hospital in Phoenix and University of Alabama at Birmingham (UAB) Hospital in Birmingham." - Anonymous Online Contributor

Unverified Answer

Are there any available openings for participants in this clinical exploration?

"Affirmative. According to the information found on clinicaltrials.gov, this trial was first made available on October 20th 2020 and has been actively recruiting since then; as of November 21st 2022 it is still looking for 15 participants from 15 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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