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

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ClinicalTrials.gov Identifier: NCT02541877
Recruitment Status : Not yet recruiting
First Posted : September 4, 2015
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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).

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Down sizing valve in type-0 BAS Device: Standard sizing valve in type-0 BAS Device: Standard sizing valve in TAS Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center,Randomized Controled Trial of Sizing-strategy of Bicuspid Aortic Valve Stenosis With Transcatheter Self-expandable Valve
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Down sizing valve in type-0 BAS
Down Sizing Transcatheter Self-expandable Valve in Type-0 BAS
Device: 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.

Active Comparator: Standard sizing valve in type-0 BAS
Standard Sizing Transcatheter Self-expandable Valve in Type-0 BAS
Device: 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.

Active Comparator: Standard sizing valve in TAS
Standard Sizing Transcatheter Self-expandable Valve in TAS
Device: 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.




Primary Outcome Measures :
  1. Number of participants with Device success [ Time Frame: 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)

  2. Changes of prosthetic valve functions [ Time Frame: From 24 hours after procedure to 5 years ]
    1. Valve hemodynamics
    2. Peri-valvular regurgitation
    3. Valve malpositioning
    4. Valve morphology


Secondary Outcome Measures :
  1. All-cause mortality and all stroke (disabling and non-disabling) [ Time Frame: 5 years ]
  2. Number of patients with procedural complications [ Time Frame: Within first 30 days ]
  3. Changes of ascending aortic diameter [ Time Frame: Changes of baseline ascending aortic diameter at 5 years ]
  4. Functional status (NYHA-classification) [ Time Frame: 5 years ]
  5. Quality of Life (SF-12) [ Time Frame: 5 years ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541877


Contacts
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Contact: Xianbao Liu, MD +86-13857173887 liuxb2009@hotmail.com
Contact: Jian-an Wang, MD,PhD +86-13805786328 Wang_jian_an@tom.com

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine at Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Xianbao Liu, MD    +86-13857173887    liuxb2009@hotmail.com   
Principal Investigator: Jian-an Wang, MD,PhD         
Sponsors and Collaborators
Jian'an Wang,MD,PhD
Investigators
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Principal Investigator: Jian-an Wang, MD,PhD Second Affiliated Hospital Zhejiang University School of Medicine

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Responsible Party: Jian'an Wang,MD,PhD, President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT02541877     History of Changes
Other Study ID Numbers: SAHZJU CT004
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction