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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

Tracking Information
First Submitted Date  ICMJE August 14, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date September 4, 2015
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2015)
  • All-cause mortality and all stroke (disabling and non-disabling) [ Time Frame: 5 years ]
  • Number of patients with procedural complications [ Time Frame: Within first 30 days ]
  • Changes of ascending aortic diameter [ Time Frame: Changes of baseline ascending aortic diameter at 5 years ]
  • Functional status (NYHA-classification) [ Time Frame: 5 years ]
  • Quality of Life (SF-12) [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
Official Title  ICMJE A Prospective, Multi-center,Randomized Controled Trial of Sizing-strategy of Bicuspid Aortic Valve Stenosis With Transcatheter Self-expandable Valve
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Down sizing valve in type-0 BAS
    Down Sizing Transcatheter Self-expandable Valve in Type-0 BAS
    Intervention: Device: Down sizing valve in type-0 BAS
  • Active Comparator: Standard sizing valve in type-0 BAS
    Standard Sizing Transcatheter Self-expandable Valve in Type-0 BAS
    Intervention: Device: Standard sizing valve in type-0 BAS
  • Active Comparator: Standard sizing valve in TAS
    Standard Sizing Transcatheter Self-expandable Valve in TAS
    Intervention: Device: Standard sizing valve in TAS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2015)
159
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xianbao Liu, MD +86-13857173887 liuxb2009@hotmail.com
Contact: Jian-an Wang, MD,PhD +86-13805786328 Wang_jian_an@tom.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02541877
Other Study ID Numbers  ICMJE SAHZJU CT004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Jian'an Wang,MD,PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jian-an Wang, MD,PhD Second Affiliated Hospital Zhejiang University School of Medicine
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP