Transcatheter valve implantation for severe aortic regurgitation

Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study

This study is testing if a new heart valve procedure called TAVR can help people with severe aortic regurgitation who can't have traditional surgery due to their health risks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 60 Years to 90 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT04864145 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of transcatheter aortic valve implantation (TAVR) as a treatment for patients suffering from severe native aortic regurgitation who are at high risk for traditional surgical aortic valve replacement. The study is a prospective, multicenter, randomized trial that aims to evaluate the safety and efficacy of TAVR in patients with specific anatomical and clinical criteria. It focuses on individuals with symptomatic severe aortic regurgitation or those with impaired left ventricular function. The trial seeks to address the challenges faced by patients who are often excluded from surgical options due to advanced age or comorbidities.

Who should consider this trial

Good fit: Ideal candidates include patients with symptomatic severe aortic regurgitation or those with left ventricular dysfunction who are at high surgical risk.

Not a fit: Patients with pure native aortic regurgitation who do not meet the study's specific anatomical and clinical criteria may not benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with severe aortic regurgitation who are not candidates for traditional surgery.

How similar studies have performed: Previous small, retrospective studies have suggested that off-label use of TAVR may be a feasible option for high-risk patients with aortic regurgitation, indicating potential for success in this novel approach.

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Jun-Jie Zhang, MD, PhD

Conditions Aortic Valve Disease