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Tests treatment safety and results for Severe Aortic Stenosis
Official title 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
ClinicalTrials.gov ID: NCT06136429
What this study is testing
- What it's testing
- 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 stenosis Test device: Transcatheter aortic valve system. Pilot Phase: Clinical Validation of Class III Medical Devices.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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;
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.