Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve

Study Overview
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Brief Summary
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To observe the clinical outcomes of the different valve sizing strategies treating type-0 Bicuspid Aortic Stenosis (BAS) with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard sizing strategy of normal Tricuspid Aortic Stenosis(TAS).

Detailed Description
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BACKGROUND: From our current clinical experience, investigators mostly choose the smaller self-expandable transcatheter valve for type-0 BAS than that for TAS, combined with balloon sizing strategy. But no prospective and randomized studies show the rationality and clinical outcomes of different sizing strategies of type-0 BAS with self-expandable transcatheter valve. AIM: To observe the clinical outcomes of the different valve sizing strategies treating type-0 BAS with self-expandable transcatheter aortic valve implantation (TAVI) valve, compared with those of a standard sizing strategy of normal TAS. POPULATION: All patients with severe degenerative aortic valve stenosis referred for aortic valve intervention will be screened for study eligibility. To be included subjects must be 65 years or older, anatomical and technical eligible for both interventions, expected to survive more than 1 year after the intervention, and able to provide written informed consent. Study exclusion criteria include isolated aortic valve regurgitation or other significant valve disease, unstable preoperative condition. DESIGN: The project is a multicenter randomized clinical trial. Patients of type-0 BAS fulfilling all inclusion and no exclusion criteria will be randomized into either Down sizing group or Standard sizing group. Randomization will be 1:1 with 53 subjects in each group. Meanwhile patients of TAS fulfilling all inclusion and no exclusion criteria will be included as a Standard group in this study. Screening and inclusion will commence in September 2015. Inclusion is expected to last 3 years, and subjects will be followed for 5 years.

Official Title
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A Prospective, Multi-center,Randomized Controled Trial of Sizing-strategy of Bicuspid Aortic Valve Stenosis With Transcatheter Self-expandable Valve

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Down sizing valve in type-0 BAS
* Device: Standard sizing valve in type-0 BAS
* Device: Standard sizing valve in TAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope) Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed. Patients are technical and anatomical eligible for interventions Exclusion Criteria: A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media Subject refuses a blood transfusion. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging. Life expectancy is less than one year

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Down sizing valve in type-0 BAS<br>Down Sizing Transcatheter Self-expandable Valve in Type-0 BAS | Device: Down sizing valve in type-0 BAS<br>* Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Down sizing valve implantation will be used in type-0 BAS.<br>|
| Active Comparator: Standard sizing valve in type-0 BAS<br>Standard Sizing Transcatheter Self-expandable Valve in Type-0 BAS | Device: Standard sizing valve in type-0 BAS<br>* Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in type-0 BAS.<br>|
| Active Comparator: Standard sizing valve in TAS<br>Standard Sizing Transcatheter Self-expandable Valve in TAS | Device: Standard sizing valve in TAS<br>* Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in TAS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Device success | Absence of procedural mortality Correct positioning of a single prosthetic heart valve into the proper anatomical location Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation) | At 24 hours after procedure | 
| Changes of prosthetic valve functions | Valve hemodynamics Peri-valvular regurgitation Valve malpositioning Valve morphology | From 24 hours after procedure to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality and all stroke (disabling and non-disabling) |  | 5 years | 
| Number of patients with procedural complications |  | Within first 30 days | 
| Changes of ascending aortic diameter |  | Changes of baseline ascending aortic diameter at 5 years | 
| Functional status (NYHA-classification) |  | 5 years | 
| Quality of Life (SF-12) |  | 5 years |