Not a traditional drug phase: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System for Tricuspid Valve Regurgitation
Pivotal trial to measure the safety and clinical how well it works of the VDyne TriNova System for the treatment of symptomatic severe or greater tricuspid regurgitation.
Official registry: https://clinicaltrials.gov/study/NCT07516444 · VDyne, Inc. · enrollment listed as 520
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System, or Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System. The registry lists allocation as randomized. Pivotal trial to measure the safety and clinical how well it works of the VDyne TriNova System for the treatment of symptomatic severe or greater tricuspid regurgitation.
They plan to enroll about 520 people at 12 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation
Interventions: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
Primary outcome (registry wording): Composite of major adverse events (MAEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Subject is willing and able to comply with all study evaluations and provide consent
- Subject must agree not to participate in any other clinical trial for a period of one year following index procedure
- New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory
- At least severe symptomatic tricuspid regurgitation
- Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR
- Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement
- Functional and/or degenerative TR graded as at least severe
Who the registry excludes
- Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study
- Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure
- Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically
- Life expectancy ≤12 months due to non-cardiac comorbidities
- Current IV Drug user (must be free from drug abuse for ≥1 year)
- Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System
- Hypersensitivity to metals (such as nickel or titanium)
Public study contact (from the registry)
Vinny Podichetty
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
12 listed- Banner Health — Phoenix, Arizona (recruiting)
- Honor Health — Scottsdale, Arizona (recruiting)
- Sutter Health/ California Pacific Medical Center — San Francisco, California (recruiting)
- Kaiser Permanente San Francisco — San Francisco, California (recruiting)
- Ascension Via Christi Hospital — Wichita, Kansas (recruiting)
- Henry Ford Hospital — Detriot, Michigan (recruiting)
- Minneapolis Heart Institute — Minneapolis, Minnesota (recruiting)
- Mayo Clinic — Rochester, Minnesota (recruiting)
- The Christ Hospital — Cincinnati, Ohio (recruiting)
- Oregon Health and Science Unversity — Portland, Oregon (recruiting)
- Medical University of South Carolina — Charleston, South Carolina (recruiting)
- Intermountain Medical Center — Murray, Utah (recruiting)
FAQ about this NCT record
Is NCT07516444 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07516444?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07516444?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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