An observational study in Tricuspid Regurgitation, sponsored by Montefiore Medical Center. Recruiting at 31 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Montefiore Medical Center · Observational
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Among 60 studies in Tricuspid Valve Insufficiency with a site in United States — 28 open to participants now, 36 under way, none of them phase 3. Tricuspid Valve Insufficiency · United States.
Among the 60 studies in Tricuspid Valve Insufficiency with a site in United States, this one is the 8th largest by planned enrollment of the 18 observational ones that give a count, is one of 4 that started in 2023, is one of 18 observational ones, reaches primary completion later than 26 of the 35 other live ones, and was the 38th registered.
227 studies on the registry are indexed under Tricuspid Valve Insufficiency; 110 are open to participants now.
Browse Tricuspid Valve Insufficiency studies →28 of the 60 studies in Tricuspid Valve Insufficiency with a site in United States are open now. Recruiting first, the newest first:
Medtronic Cardiovascular · Sites in United States
Ages 18+
Laplace Interventional, Inc · Sites in United States
Ages 18–90
VDyne, Inc. · Sites in United States
Ages 18+
Jenscare Innovation Inc. · Sites in United States, Canada
Ages 21+
TRiCares · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 82 Tricuspid Valve Insufficiency studies recruiting now, 68 (83%) set no upper age limit and none (0%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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60 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 800 is above the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Median enrollment 63 across the 42 interventional studies, 464 across the 18 observational. Of the 19 that completed or were terminated, 7 (37%) have results posted.
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37 of 60 have an industry lead sponsor. The 10 most frequent:
Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Montefiore Medical Center has 1 study filed under Tricuspid Valve Insufficiency — fewer than ten, so there is no comparison to draw.
8 of the studies in Tricuspid Valve Insufficiency with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05848284VDyne, Inc.Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) | 2026-11-30 |
| NCT05825898Ottawa Heart Institute Research CorporationOutcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment | 2026-12 |
| NCT06212193Innoventric LTDInnoventric Trillium™ Stent Graft Early Feasibility Study (EFS) | 2026-12-20 |
| NCT03382457Edwards LifesciencesClinical Study of Edwards Cardioband FIT Valve Repair System | 2026-12-31 |
| NCT06077201Vanderbilt University Medical CenterHome-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions | 2027-02-01 |
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Among the 60 studies in Tricuspid Valve Insufficiency with a site in United States, from their registry updates:
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The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.
The primary aims of the registry will be:
Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.
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Exclusion Criteria:
Patients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement
Device: Transcatheter Tricuspid Valve Replacement
All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease
Freedom from device-related complications
Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications
Time frame: 30 days after the index procedure
Reduction in Tricuspid Regurgitation Severity
Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed
Time frame: 30 days after the index procedure
Permanent Pacemaker Implantation
The number of participants who have received a permanent pacemaker implantation will be recorded
Time frame: 30 days after the index procedure
Combined all-cause mortality or rehospitalization for congestive heart failure
The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded
Time frame: 12 months after the index procedure
All-cause mortality
The number of deaths due to any cause will be recorded
Time frame: 12 months after the index procedure
Hospitalization for congestive heart failure
The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded
Time frame: 12 months after the index procedure
The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure
The number of participants who meet either NYHA III or NYHA IV classifications for heart failure will be recorded. NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients
Time frame: 12 months after the index procedure
Device Thrombosis
The number of participants who have been identified with device thrombosis will be recorded
Time frame: 12 months after the index procedure
Tricuspid Regurgitation Severity
Tricuspid Regurgitation is measured by transthoracic echocardiography. Assessment of MI severity will be conducted in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Higher mean scores are indicative of greater TR severity
Time frame: 12 months after the index procedure
Quality of Life - Kansas City Cardiomyopathy Questionnaire
Quality of Life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ has a 2-week recall period and includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score that mirrors the key concepts of the NYHA functional class. The symptom, physical limitations, social limitations, and quality of life domains are combined to create an overall summary score, which is the primary health status outcome All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life
Time frame: 12 months after the index procedure
Tricuspid Valve Reintervention
The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded
Time frame: 12 months after the index procedure
Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for Dec 2028, 62 months after the start.
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