A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

Launched by PAN XIANGBIN · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients with severe aortic stenosis, a condition where the heart's aortic valve becomes narrowed, making it difficult for the heart to pump blood. The study will evaluate the safety and effectiveness of a device called a transcatheter aortic valve system. It aims to enroll around 120 patients who are typically over the age of 70 and have symptoms like shortness of breath or fatigue due to their heart condition. Participants will need to meet specific health criteria, such as having a certain level of heart function and being unsuitable for traditional heart surgery.

If you or a loved one joins the trial, you can expect to receive the new valve using a minimally invasive procedure, followed by regular check-ups for up to five years to monitor heart health and overall quality of life. The goal is to see how well the device works and to track any complications or improvements in symptoms. Participation also requires a commitment to understanding the study and signing a consent form. This trial is currently recruiting participants, and your involvement could help advance treatment options for others with similar heart conditions.

Gender

ALL

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.