Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Apr 24, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for people with severe aortic regurgitation, a condition where the heart's aortic valve does not close properly, causing blood to flow backward into the heart. The trial is looking at a procedure called transcatheter self-expandable valve implantation, which is a less invasive way to replace the damaged valve compared to traditional surgery. The study is currently recruiting participants aged between 21 and 87 who are experiencing significant symptoms or have specific heart measurements indicating severe aortic regurgitation.

To be eligible for this trial, participants should have severe symptoms related to their heart condition or certain heart function measurements that are below normal. They may also be individuals who are considered at high risk for traditional surgery due to other health issues. If you join the study, you can expect to receive close monitoring and care as part of the trial process. It’s important to know that there are specific criteria that exclude certain individuals, such as those under 60 years old or with other serious heart conditions. If you think you or someone you know might qualify, discussing this opportunity with a healthcare provider could be beneficial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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 dimension (LVESD) \> 50mm;
• • 2. Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm;
• • 3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
• 4. 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:
• • 1. Severe aorta calcification or active ascending aorta atherosclerotic plaque
• • 2. History of mediastinum radiotherapy
• • 3. Past mediastinitis
• • 4. Presence of unobstructed coronary bypass implants
• • 5. Previous more than two cardiothoracic surgeries
• • 6. Liver cirrhosis
• • 7. Other surgical risk factors
• Exclusion Criteria:
• • 1. Age \< 60 years old;
• • 2. Ascending aorta diameter \>45mm;
• • 3. Coronary multi-vessel disease (SYNTAX score \>32);
• • 4. Life expectancy \<1 year;
• • 5. Left ventricular ejection fraction \<30%;
• • 6. Acute myocardial infarction within 30 days;
• • 7. Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);
• • 8. Other situations judged by the researcher as unsuitable for participating in the study.