Transcatheter valve implantation for severe aortic regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanjing First Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jun-Jie Zhang, MD, PhD
• Email: jameszll@163.com
• Phone: +86-25-52271350

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• KONECT RESILIA Aortic Valved Conduit real-world use in adults needing valve and ascending aorta replacement

  This study tests how the KONECT RESILIA aortic valved conduit performs in adults needing aortic valve and ascending aorta replacement.

  Recruiting at 3 sites Edwards Lifesciences · München, Bavaria and 2 other locations · NCT07619872

• Savvywire versus standard LV guidewires during transfemoral TAVI

  For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.

  Recruiting Catharina Ziekenhuis Eindhoven · Eindhoven, North Brabant · NCT07366671

• EmStop Embolic Protection System for TAVR in Aortic Valve Stenosis

  This study tests whether the EmStop protective device can safely capture and remove debris during transcatheter aortic valve replacement in adults with severe aortic valve stenosis.

  Recruiting at 7 sites EmStop Inc · Thousand Oaks, California and 6 other locations · NCT07276711

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Real-world outcomes of the INSPIRIS RESILIA aortic valve in adults

  This registry will collect real-world data to see how the INSPIRIS RESILIA aortic valve performs in adults undergoing aortic valve replacement.

  Recruiting at 15 sites Edwards Lifesciences · Heidelberg, Baden-Wurttemberg and 14 other locations · NCT07120048

• Transcatheter JenaValve or J-Valve treatment for severe aortic regurgitation

  This project will try two transcatheter heart valves (JenaValve and J-Valve) to treat people with severe symptomatic aortic regurgitation who are high risk for open-heart surgery.

  Recruiting Prince of Wales Hospital, Shatin, Hong Kong · Hong Kong, Shatin · NCT07021612

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.