Aortic Valve Stenosis
Conditions
Brief summary
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
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.
Interventions
DEVICEDown sizing valve in type-0 BAS
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.
DEVICEStandard sizing valve in type-0 BAS
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.
DEVICEStandard sizing valve in TAS
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.
Sponsors
Jian'an Wang,MD,PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed. 4. Patients are technical and anatomical eligible for interventions
Exclusion criteria
1. 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 2. Subject refuses a blood transfusion. 3. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. 4. Native aortic annulus size \< 20 mm or \> 29 mm per the baseline diagnostic imaging. 5. Life expectancy is less than one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Device success | At 24 hours after procedure | 1. Absence of procedural mortality 2. Correct positioning of a single prosthetic heart valve into the proper anatomical location 3. 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) |
| Changes of prosthetic valve functions | From 24 hours after procedure to 5 years | 1. Valve hemodynamics 2. Peri-valvular regurgitation 3. Valve malpositioning 4. Valve morphology |
Secondary
| Measure | Time frame |
|---|---|
| Changes of ascending aortic diameter | Changes of baseline ascending aortic diameter at 5 years |
| All-cause mortality and all stroke (disabling and non-disabling) | 5 years |
| Quality of Life (SF-12) | 5 years |
| Functional status (NYHA-classification) | 5 years |
| Number of patients with procedural complications | Within first 30 days |
Countries
China
Contacts
Primary ContactXianbao Liu, MD
Backup ContactJian-an Wang, MD,PhD
Outcome results
None listed