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New treatment option for AORTIC VALVE DISEASES
Official title TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System
ClinicalTrials.gov ID: NCT06818084
What this study is testing
What is VitaFlow+GDMT?
VitaFlow+GDMT is an investigational medicine, being studied as a potential treatment for aortic valve diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) .
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation.
- Asymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria:
- LVEF ≤ 55% (measured by biplane Simpson's method); LVESD \> 50 mm ; LVESDi \> 22 mm/mm²； LVESVi \> 45mL/m2 Anatomical suitability for TAVR as...
You likely can't join if
- Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses.
- Life expectancy \< 1 year. LVEF \< 45%. eGFR \< 30 mL/min/1.73m². Known allergy or contraindication to required medications (e.g., aspirin...
- Any condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation.
- Poor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.