Evaluating a new heart valve system for patients with severe aortic stenosis

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 is designed to assess the safety and efficacy of a transcatheter aortic valve system in treating patients diagnosed with severe aortic stenosis. It is a prospective, multicenter, single-arm study involving 120 participants who are at least 70 years old and have symptomatic severe aortic stenosis. The primary endpoint is to evaluate all-cause mortality within 12 months post-procedure, while secondary endpoints include device and procedural success rates. The trial aims to provide a less invasive treatment option for patients who are not suitable candidates for traditional surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age≥ 70 years;
2. Patients with symptomatic severe aortic stenosis (mean pressure gradient across the aortic valve ≥ 40 mmHg (1 mmHg = 0.133 kPa) on echocardiography, or trans-aortic valve blood flow velocity ≥ 4.0 m/s, or aortic orifice area ≤ 1.0 cm2, or effective aortic orifice area index ≤0.6 cm2/m2)
3. NYHA Grading ≥ Level II;
4. Life expectancy of more than 1 year after implantation of the prosthetic valve;
5. Assessed by not less than two cardiothoracic surgeons, documented as a contraindication to surgery, or documented as unsuitable for conventional surgery;
6. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-up.

Exclusion Criteria:

1. The imaging data shows that it is anatomically unsuitable for transcatheter aortic valve implantation;
2. Acute myocardial infarction (defined as Q-wave myocardial infarction, or non-Q-wave myocardial infarction with CK-MB≥ twice normal and/or elevated Tn (WHO definition)) occurring within 1 month before valve implantation);
3. Received any therapeutic traumatic cardiac surgery (other than coronary revascularization) within 1 month before valve implantation;
4. Implanted prosthetic heart valves at any location, or combined with other valves with severe stenosis or severe regurgitation;
5. Hemorrhagic constitution or coagulation dysfunction (platelet PLT\<50×10\^9/L);
6. Haemodynamic instability requiring continuous mechanical cardiac assistance;
7. Severe left ventricular dysfunction, left ventricular ejection fraction LVEF \<20%;
8. Echocardiography shows intracardiac thrombosis or vegetation, etc.;
9. Renal insufficiency decompensation (endogenous creatinine clearance rate\<20ml/min);
10. Active peptic ulcer or upper gastrointestinal bleeding within 3 months;
11. Cerebrovascular events (CVAs) within 3 months before valve implantation, excluding transient ischemic attack;
12. Allergy or contraindication to antiplatelet drugs, anticoagulant drugs, or contrast agents, resulting in the inability to perform preoperative or appropriate intraoperative medication, allergies, or contraindications to polymer materials;
13. Patients with active infective endocarditis or other active infections;
14. Concurrent participation in other drug or device studies.
15. In the opinion of the investigator, it is not suitable for enrollment.

Where it's running

• Beijing
  Beijing, China Recruiting

Study contacts

• Study coordinator: TAO chunli
• Email: taochunli@silaragroup.com
• Phone: 13701152794

Similar studies

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

• Registry of Transcatheter Aortic Valve Treatments at a Italian Center

  This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.

  Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT07596394

• CT-FFR-guided revascularization for people with severe aortic stenosis

  This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.

  Recruiting Yan'an Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07469371

• RENATUS transcatheter aortic valve for severe aortic stenosis

  This trial tests the RENATUS transcatheter aortic valve in people with symptomatic severe aortic stenosis who are eligible for TAVR.

  Recruiting at 4 sites Beijing Balance Medical Technology Co., Ltd · Beijing and 3 other locations · NCT07414342

• Pre-emptive LAVA-ECMO support for complex, high-risk TAVR

  The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.

  Recruiting at 2 sites Atlantic Health System · Detroit, Michigan and 1 other locations · NCT07309029

• Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis

  This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.

  Recruiting Anteris Technologies Ltd. · Copenhagen, Capital Region of Denmark · NCT07194265

• Navitor TAVI valve in Japanese patients with severe aortic stenosis

  This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.

  Recruiting at 3 sites Abbott Medical Devices · Fukuoka and 2 other locations · NCT07193888

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.