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

Aortic Valve Stenosis Clinical Trial

— START  

Official title:

A Prospective, Multi-center,Randomized Controled Trial of Sizing-strategy of Bicuspid Aortic Valve Stenosis With Transcatheter Self-expandable Valve

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02541877
• Other study ID #: SAHZJU CT004
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 14, 2015
• Last updated: September 3, 2015
• Start date: September 2015
• Est. completion date: September 2023

Study information

• Verified date: September 2015
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xianbao Liu, MD
• Phone: +86-13857173887
• Email: liuxb2009[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 159
• Est. completion date: September 2023
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

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

• Aortic Valve Stenosis
• Constriction, Pathologic
• Heart Valve Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine at Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jian'an Wang,MD,PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Device success	Absence of procedural mortality; Correct positioning of a single prosthetic heart valve into the proper anatomical location; 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)	At 24 hours after procedure	Yes
Primary	Changes of prosthetic valve functions	Valve hemodynamics; Peri-valvular regurgitation; Valve malpositioning; Valve morphology	From 24 hours after procedure to 5 years	Yes
Secondary	All-cause mortality and all stroke (disabling and non-disabling)		5 years	Yes
Secondary	Number of patients with procedural complications		Within first 30 days	Yes
Secondary	Changes of ascending aortic diameter		Changes of baseline ascending aortic diameter at 5 years	No
Secondary	Functional status (NYHA-classification)		5 years	No
Secondary	Quality of Life (SF-12)		5 years	No