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

A Prospective, Multicenter, Single-arm Target-value Clinical Trial To Evaluate the Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

This study is testing a new heart valve system to see if it can safely help older patients with severe aortic stenosis who can’t have regular surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06136429 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 70 and older with symptomatic severe aortic stenosis who are deemed unsuitable for conventional surgery.

Not a fit: Patients with anatomical conditions that make them unsuitable for transcatheter aortic valve implantation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a safer and effective treatment option for elderly patients suffering from severe aortic stenosis.

How similar studies have performed: Other studies have shown promising results with transcatheter aortic valve replacement, indicating that this approach is gaining acceptance in clinical practice.

Eligibility criteria

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 this trial is running

Beijing

• Beijing — Beijing, China (Recruiting)

Study contacts

• Study coordinator: TAO chunli

Conditions Severe Aortic Stenosis