Status:
RECRUITING
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
Lead Sponsor:
Pan Xiangbin
Conditions:
Severe Aortic Stenosis
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
Trial Title: Prospective, multicenter, single-arm target value clinical trial to evaluate the safety and efficacy of a transcatheter aortic valve system in the treatment of patients with severe aortic...
Eligibility Criteria
Inclusion
- Age≥ 70 years;
- 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)
- NYHA Grading ≥ Level II;
- Life expectancy of more than 1 year after implantation of the prosthetic valve;
- Assessed by not less than two cardiothoracic surgeons, documented as a contraindication to surgery, or documented as unsuitable for conventional surgery;
- 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
- The imaging data shows that it is anatomically unsuitable for transcatheter aortic valve implantation;
- 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);
- Received any therapeutic traumatic cardiac surgery (other than coronary revascularization) within 1 month before valve implantation;
- Implanted prosthetic heart valves at any location, or combined with other valves with severe stenosis or severe regurgitation;
- Hemorrhagic constitution or coagulation dysfunction (platelet PLT\<50×10\^9/L);
- Haemodynamic instability requiring continuous mechanical cardiac assistance;
- Severe left ventricular dysfunction, left ventricular ejection fraction LVEF \<20%;
- Echocardiography shows intracardiac thrombosis or vegetation, etc.;
- Renal insufficiency decompensation (endogenous creatinine clearance rate\<20ml/min);
- Active peptic ulcer or upper gastrointestinal bleeding within 3 months;
- Cerebrovascular events (CVAs) within 3 months before valve implantation, excluding transient ischemic attack;
- 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;
- Patients with active infective endocarditis or other active infections;
- Concurrent participation in other drug or device studies.
- In the opinion of the investigator, it is not suitable for enrollment.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06136429
Start Date
October 18 2023
End Date
December 30 2029
Last Update
November 18 2023
Active Locations (1)
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1
Beijing
Beijing, China