Transcatheter Tricuspid Valve Reconstruction for Tricuspid Regurgitation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tricuspid RegurgitationTranscatheter Tricuspid Valve Reconstruction - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and performance of a new device to treat tricuspid valve disease.

Eligible Conditions
  • Tricuspid Regurgitation

Treatment Effectiveness

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 30 days, 6 Months, 12 Months

30 days
Clinical Success
Composite Major Adverse Event (MAE) Rate
Freedom from device or procedure-related adverse events
Month 12
Health Status
Six minute walk test
Month 12
NYHA Functional Class
Reduction in TR grade
Discharge (2-7 days)
Procedural Success
Intraprocedural
Device Success

Trial Safety

Trial Design

1 Treatment Group

Treatment
1 of 1

Experimental Treatment

55 Total Participants · 1 Treatment Group

Primary Treatment: Transcatheter Tricuspid Valve Reconstruction · No Placebo Group · N/A

Treatment
Device
Experimental Group · 1 Intervention: Transcatheter Tricuspid Valve Reconstruction · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days, 6 months, 12 months

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
164 Previous Clinical Trials
57,865 Total Patients Enrolled
William Gray, MDPrincipal InvestigatorLankenau Heart
8 Previous Clinical Trials
3,307 Total Patients Enrolled
Firas Zahr, MDPrincipal InvestigatorOregon Health and Science University

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The local site determines that the patient is appropriate for transcatheter tricuspid reconstruction.