A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China

Plain English Summary

A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China is a Not Applicable clinical trial sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital studying Aortic Stenosis, AORTIC VALVE DISEASES. This study will look at how well the SAPIEN 3 artificial heart valve works and how safe it is for people in China with a specific type of aortic valve problem called Type-0 bicuspid aortic stenosis. It is for patients aged 50 and older who have severe aortic stenosis and a specific heart valve anatomy (Type-0 bicuspid). Participation involves receiving the SAPIEN 3 valve through a minimally invasive procedure and attending follow-up appointments. Alternatives may include open-heart surgery to replace the valve or other types of transcatheter valve replacements, depending on individual patient factors and physician recommendation. The trial aims to enroll 170 participants.

Official Summary

In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 50 or older, have been diagnosed with severe aortic stenosis, and have a confirmed Type-0 bicuspid aortic valve. You cannot join if you have certain other heart conditions, severe blockages in your leg arteries, have had a recent heart attack or stroke, or have a life expectancy of less than 24 months. Specific health requirements include having adequate blood vessels for the procedure and being able to return for all scheduled follow-up visits. This trial is studying Aortic Stenosis, AORTIC VALVE DISEASES, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see how often patients experience death, stroke, or need to be readmitted to the hospital within one year of receiving the SAPIEN 3 valve, giving an overall picture of its effectiv The specific primary outcome measures are: The composite of all-cause mortality, stroke, or rehospitalization (At 1 year after procedure). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it addresses a challenging group of patients with bicuspid aortic valves, for whom current valve replacement options may be less straightforward, potentially filling a This research targets Aortic Stenosis, AORTIC VALVE DISEASES, where improved treatment options are needed.

Investor Insight

This observational study on the SAPIEN 3 valve in a specific patient group in China signals potential market expansion and further validation for the device in diverse anatomical presentations, sugges

Is This Trial Right for Me?

Ask your doctor if the SAPIEN 3 valve is the right choice for your specific type of aortic valve problem and if you meet all the study requirements. Be prepared for a minimally invasive procedure where the new valve is delivered through a tube inserted into a blood vessel, usually in the leg. You will need to attend regular check-ups after the procedure to monitor your heart's health and how the new valve is functioning. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 170 participants

Interventions

• DEVICE: Transcatheter Aortic Valve Replacement — Transcatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis.

Primary Outcomes

• The composite of all-cause mortality, stroke, or rehospitalization (At 1 year after procedure)

Secondary Outcomes

• The composite of all-cause mortality, stroke, or rehospitalization (At 30 days after procedure)
• The composite of device success (At 30 days after procedure)
• Annular rupture (At discharge(assessed up to 30 days))
• Paravalvular leakage (At discharge (assessed up to 30 days) , 30 days, 1year)
• Technical success (At exit from procedure room)

Full Eligibility Criteria

Inclusion Criteria:

* 50 years of age or older.
* Physicians decide to use ABCS bicuspid sizing approach for the subjects.
* Severe AS, defined as follows:
* a) For symptomatic patients:
* i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest
* b) For asymptomatic patients:
* i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR
* ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
* iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%.
* Type-0 bicuspid aortic valve anatomy confirmed by multi-detector computed tomography (MDCT).
* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
* Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.
* The study patient has provided written informed consent.

Exclusion Criteria:

* Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases)
* Aortic valve is a congenital unicuspid valve, congenital Type-1 or Type-2 bicuspid valve, tricuspid or quadricuspid valve
* Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR
* Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia
* Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease)
* Aortic disease: bicuspid aortic valve with an ascending aorta diameter ≥50mm
* Pre-existing mechanical or bioprosthetic valve in any position
* Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit
* Emergency interventional/surgical procedures within 30 days of the valve implant procedure
* Hypertrophic cardiomyopathy with or without obstruction
* Ventricular dysfunction with LVEF \< 30%
* Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation
* Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel
* Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure
* Renal replacement therapy at the time of screening
* Severe lung disease (FEV1 \< 50% predicted) or currently on home oxygen
* Estimated life expectancy \< 24 months
* Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.

Trial Locations

• Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing, Beijing, Beijing Municipality, China

Frequently Asked Questions

Related Conditions

• Aortic Stenosis
• Bicuspid Aortic Valve
• Aortic Valve Disease
• Heart Valve Stenosis
• Transcatheter Aortic Valve Replacement (TAVR)
• Cardiovascular Disease
• Valvular Heart Disease
• Congenital Heart Defects
• Heart Failure
• Coronary Artery Disease

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