Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02541877
Study type	Interventional
Source	Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact	Xianbao Liu, MD
Phone	+86-13857173887
Email	liuxb2009@hotmail.com
Status	Not yet recruiting
Phase	Phase 3
Start date	September 2015
Completion date	September 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms