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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Jian'an Wang,MD,PhD

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Second Affiliated Hospital, School of Medicine, Zhejiang University

Dates:
Date Received: August 14, 2015
Date Started: September 2015
Date Completion: September 2023
Last Updated: September 3, 2015
Last Verified: September 2015