Aortic Stenosis, AORTIC VALVE DISEASES
Conditions
Keywords
Balloon-expandable transcatheter heart valve, TAVR, aortic stenosis
Brief 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.
Interventions
DEVICETranscatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite of all-cause mortality, stroke, or rehospitalization | At 1 year after procedure | The composite of all-cause mortality, stroke, or rehospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The composite of all-cause mortality, stroke, or rehospitalization | At 30 days after procedure | The composite of all-cause mortality, stroke, or rehospitalization |
| The composite of device success | At 30 days after procedure | 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 |
| Annular rupture | At discharge(assessed up to 30 days) | Annular rupture |
| Paravalvular leakage | At discharge (assessed up to 30 days) , 30 days, 1year | Paravalvular leakage |
| Technical success | At exit from procedure room | 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 |
| Procedural success | At 30 days | 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 |
| Mortality (all cause & cardiovascular) | At 30 days,1year | Mortality (all cause \& cardiovascular) |
| Stroke (disabling and nondisabling) | At 30 days, 1year | Stroke (disabling and nondisabling) |
| Rehospitalization (procedure, valve and heart failure related) | At 30 days, 1year | Rehospitalization (procedure, valve and heart failure related) |
| Major vascular complication | At 30 days, 1year | Major vascular complication |
| Major or life-threatening bleeding | At 30 days, 1year | Major or life-threatening bleeding |
| Myocardial infarction | At 30 days, 1year | Myocardial infarction |
| Acute kidney injury stage 2 or 3 | At 30 days, 1year | Acute kidney injury stage 2 or 3 |
| Need for a permanent pacemaker | At 30 days, 1year | Need for a permanent pacemaker |
| New onset atrial fibrillation | At 30 days, 1year | New onset atrial fibrillation |
| Valve endocarditis | At 30 days, 1year | Valve endocarditis |
| Valve thrombosis | At 30 days, 1year | Valve thrombosis |
| New York Heart Association class | At 30 days, 1year | New York Heart Association class |
| Patient-prosthesis mismatch | At 30 days, 1year | Patient-prosthesis mismatch |
| Index hospitalization days | At discharge (assessed up to 30 days) | Index hospitalization days |
| Health status as evaluated by Quality of Life questionnaires - KCCQ | At baseline, 30 days, 1year | Health status as evaluated by Quality of Life questionnaires - KCCQ |
Countries
China
Contacts
CONTACTXiangbin Pan, MD,PhD
CONTACTNing Zhou
PRINCIPAL_INVESTIGATORXiangbin Pan
Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing
Outcome results
None listed