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New treatment option for Aortic Valve Disease
Official title Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
ClinicalTrials.gov ID: NCT04864145
What this study is testing
What is Medical therapy?
Medical therapy is an investigational medicine, being studied as a potential treatment for aortic valve disease.
Also referred to as Optimal medical therapy.
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
- Prospective, multicenter, randomized trial.
- 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 to 90
You may be able to join if
- Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular...
- Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm;
- The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
- STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult...
- Severe aorta calcification or active ascending aorta atherosclerotic plaque
You likely can't join if
- Age \< 60 years old;
- Ascending aorta diameter \>45mm;
- Coronary multi-vessel disease (SYNTAX score \>32);
- Life expectancy \<1 year;
- Left ventricular ejection fraction \<30%;
- Acute myocardial infarction within 30 days;
See the full eligibility criteria
- Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) \> 65mm or left ventricular end-systolic...
- Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm;
- The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
- STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:
- Severe aorta calcification or active ascending aorta atherosclerotic plaque
- History of mediastinum radiotherapy
- Past mediastinitis
- Presence of unobstructed coronary bypass implants
- Previous more than two cardiothoracic surgeries
- Liver cirrhosis
- Other surgical risk factors
- Age \< 60 years old;
- Ascending aorta diameter \>45mm;
- Coronary multi-vessel disease (SYNTAX score \>32);
- Life expectancy \<1 year;
- Left ventricular ejection fraction \<30%;
- Acute myocardial infarction within 30 days;
- Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);
- Other situations judged by the researcher as unsuitable for participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, 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.