NCT07450196 - 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 | Crick

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Inclusion Criteria: * 50 years of age or older. * 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: * Challenging calcification based on physician's experience and discretion * 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 * Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease) * 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 obstruction * Ventricular dysfunction with LVEF \< 30% * Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation * Renal replacement therapy at the time of screening * Estimated life expectancy \< 12 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.

Outcomes

Primary Outcomes

The composite of all-cause mortality, stroke, or rehospitalization

Time frame: At 1 year after procedure

Secondary Outcomes

The composite of all-cause mortality, stroke, or rehospitalization

Time frame: At 30 days after procedure

The composite of device success

The composite of device success at 30 days comprising the following: freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication, intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, and less than moderate aortic regurgitation), according to the VARC-3 definition

Time frame: At 30 days after procedure

Annular rupture

Time frame: At discharge(assessed up to 30 days)

Paravalvular leakage

Time frame: At discharge (assessed up to 30 days) , 30 days, 1year

Technical success

Technical success (at exit from procedure room): * freedom from mortality * successful access, delivery of the device, and retrieval of the delivery system * correct positioning of a single prosthetic heart valve into the proper anatomical location * freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication

Time frame: At exit from procedure room

Procedural success

Procedural success at 30 days defined as meeting all of the following: * Device success * No device or procedure related SAE's as follows: 1. Life-threatening bleed (BARC 3b or greater) 2. Major vascular or cardiac structural complications requiring unplanned reintervention or surgery 3. Stage 2 or 3 AKI (includes new dialysis) 4. MI or need for PCI/CABG 5. Severe heart failure or hypotension requiring IV inotrope \>12 hours, ultrafiltration or mechanical circulatory support 6. Prolonged intubation \> 48 hours 7. Need for a permanent pacemaker implant or continuous atrial fibrillation

Time frame: At 30 days

Mortality (all cause & cardiovascular)

Mortality (all cause \& cardiovascular)

Time frame: At 30 days,1year

Stroke (disabling and nondisabling)

Time frame: At 30 days, 1year

Rehospitalization (procedure, valve and heart failure related)

Time frame: At 30 days, 1year

Major vascular complication

Time frame: At 30 days, 1year

Major or life-threatening bleeding

Time frame: At 30 days, 1year

Myocardial infarction

Time frame: At 30 days, 1year

Acute kidney injury stage 2 or 3

Time frame: At 30 days, 1year

Need for a permanent pacemaker

Time frame: At 30 days, 1year

New onset atrial fibrillation

Time frame: At 30 days, 1year

Valve endocarditis

Time frame: At 30 days, 1year

Valve thrombosis

Time frame: At 30 days, 1year

New York Heart Association class

Time frame: At 30 days, 1year

Patient-prosthesis mismatch

Time frame: At 30 days, 1year

Index hospitalization days

Time frame: At discharge (assessed up to 30 days)

Health status as evaluated by Quality of Life questionnaires - KCCQ

Time frame: At baseline, 30 days, 1year

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts