Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
NCT ID: NCT02541877
Last Updated: 2015-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
159 participants
INTERVENTIONAL
2015-09-30
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Down sizing valve in type-0 BAS
Down Sizing Transcatheter Self-expandable Valve in Type-0 BAS
Down 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.
Standard sizing valve in type-0 BAS
Standard Sizing Transcatheter Self-expandable Valve in Type-0 BAS
Standard 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.
Standard sizing valve in TAS
Standard Sizing Transcatheter Self-expandable Valve in TAS
Standard 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.
Interventions
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Down 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.
Standard 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.
Standard 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.
Eligibility Criteria
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Inclusion Criteria
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
* 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
65 Years
ALL
No
Sponsors
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Jian'an Wang,MD,PhD
OTHER
Responsible Party
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Jian'an Wang,MD,PhD
President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
Principal Investigators
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Jian-an Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital Zhejiang University School of Medicine
Locations
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2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SAHZJU CT004
Identifier Type: -
Identifier Source: org_study_id
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