Actively Recruiting
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
Led by Pan Xiangbin · Updated on 2023-11-18
120
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a transcatheter aortic valve system for patients with severe aortic stenosis, a serious heart valve condition. This prospective, multicenter, single-arm clinical trial plans to enroll 120 patients aged 70 years or older who have been diagnosed with symptomatic severe aortic stenosis and are not suitable candidates for conventional surgery. The trial aims to measure all-cause mortality within 12 months after the valve implantation as the primary outcome. Participants will receive the transcatheter aortic valve replacement using the Silara SR Heart Valve System. The study involves a single treatment group where all patients undergo this procedure. After implantation, patients will be closely monitored at several time points including immediately post-operation, at 7 days or discharge, 30 days, 6 months, 12 months, and annually up to 5 years. These visits will assess valve function, procedural success, device performance, improvements in cardiac function and quality of life, and any complications. During the study, patients will have regular clinical follow-ups involving imaging tests such as ultrasound, laboratory tests, and safety evaluations to monitor heart valve performance and overall health. Researchers will collect detailed clinical data to analyze device success, cardiac function improvements, mortality rates, and major adverse events up to five years post-procedure. The total participation time includes follow-ups up to 5 years to evaluate long-term safety and effectiveness of the valve system.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- Diagnosed with symptomatic severe aortic stenosis (mean pressure gradient 40 mmHg, or valve blood flow velocity 4.0 m/s, or aortic orifice area 1.0 cm2, or effective orifice area index 0.6 cm2/m2) confirmed by echocardiography
- New York Heart Association (NYHA) functional class II or higher
- Expected life expectancy of more than 1 year after valve implantation
- Evaluated by at least two cardiothoracic surgeons and documented as unsuitable for conventional surgery
- Able to understand the trial purpose, give informed consent, and willing to comply with study procedures and follow-up
You will not qualify if you...
- Anatomically unsuitable for transcatheter aortic valve implantation based on imaging
- Acute myocardial infarction within 1 month before implantation
- Cardiac surgery (except coronary revascularization) within 1 month before implantation
- Existing prosthetic heart valves or severe disease of other valves
- Bleeding or clotting disorders (platelet count less than 50 x 10^9/L)
- Hemodynamic instability needing continuous mechanical cardiac support
- Severe left ventricular dysfunction (ejection fraction less than 20%)
- Presence of intracardiac thrombosis or vegetation
- Severe kidney failure (creatinine clearance less than 20 ml/min)
- Active peptic ulcer or upper gastrointestinal bleeding within 3 months
- Stroke or cerebrovascular event within 3 months (except transient ischemic attack)
- Allergy or contraindication to antiplatelet, anticoagulant drugs, contrast agents, or polymer materials
- Active infective endocarditis or other infections
- Participation in other drug or device clinical trials
- Investigator's judgment of unsuitability for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo transcatheter aortic valve replacement using the Transcatheter Heart Valve System (Silara SR).
1 visit (in-person) for the procedure
Duration - 12 months
Participants are monitored for safety and efficacy outcomes after the valve replacement.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Beijing
Beijing, China
Actively Recruiting
Research Team
T
TAO chunli
P
Pan Xiangbin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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