2019-06 TRISCEND Study
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ClinicalTrials.gov Identifier: NCT04221490 |
Recruitment Status :
Recruiting
First Posted : January 9, 2020
Last Update Posted : July 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases | Device: Transcatheter Tricuspid Valve Replacement | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device |
Actual Study Start Date : | May 6, 2020 |
Estimated Primary Completion Date : | October 2025 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
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Device: Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Other Name: Edwards EVOQUE Tricuspid Valve Replacement System |
- Freedom from device or procedure-related adverse events [ Time Frame: 30 days ] [ Time Frame: 30 days ]Freedom from device or procedure-related adverse events
- NYHA Functional Class [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]Number of patients with improvement in NYHA class
- Six minute walk test [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]Change in distance (m) from baseline
- Reduction in TR grade [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]Number of patients with reduction in TR from baseline
- Health Status - KCCQ [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
- Health Status - SF-36 [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]Number of points of improvement in health status as measured by 36 item short form survey (SF-36)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Functional or degenerative TR moderate or greater
- Symptomatic despite medical therapy or prior HF hospitalization from TR
- The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
Exclusion Criteria:
- Tricuspid valve anatomic contraindications
- Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
- Hemodynamic instability
- Refractory heart failure requiring advanced intervention
- Currently participating in another investigational study in which the patient has not reached a primary endpoint

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221490
Contact: TMTT Clinical | 949-250-2500 | TMTT_Clinical@Edwards.com |

Principal Investigator: | Susheel Kodali, MD | Columbia University |
Responsible Party: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT04221490 |
Other Study ID Numbers: |
2019-06 |
First Posted: | January 9, 2020 Key Record Dates |
Last Update Posted: | July 13, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Tricuspid Regurgitation Transcatheter Replacement Functional |
Degenerative Regurgitation Valve Replacement Cardiovascular Disease |
Cardiovascular Diseases Heart Valve Diseases Tricuspid Valve Insufficiency Heart Diseases |