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

NCT02541877 | Unknown Phase 3 DMC

• 1 other identifier: SAHZJU CT004
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Number of participants with Device success

  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)

  At 24 hours after procedure

• Changes of prosthetic valve functions

  1. Valve hemodynamics 2. Peri-valvular regurgitation 3. Valve malpositioning 4. Valve morphology

  From 24 hours after procedure to 5 years

Secondary Outcomes (5)

• All-cause mortality and all stroke (disabling and non-disabling)

  5 years

• Number of patients with procedural complications

  Within first 30 days

• Changes of ascending aortic diameter

  Changes of baseline ascending aortic diameter at 5 years

• Functional status (NYHA-classification)

  5 years

• Quality of Life (SF-12)

  5 years

Study Arms (3)

Down sizing valve in type-0 BAS

EXPERIMENTAL

Down Sizing Transcatheter Self-expandable Valve in Type-0 BAS

Device: Down sizing valve in type-0 BAS

Standard sizing valve in type-0 BAS

ACTIVE COMPARATOR

Standard Sizing Transcatheter Self-expandable Valve in Type-0 BAS

Device: Standard sizing valve in type-0 BAS

Standard sizing valve in TAS

ACTIVE COMPARATOR

Standard Sizing Transcatheter Self-expandable Valve in TAS

Device: Standard sizing valve in TAS

Interventions

Down sizing valve in type-0 BAS DEVICE

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.

Down sizing valve in type-0 BAS

Standard sizing valve in type-0 BAS DEVICE

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 type-0 BAS

Standard sizing valve in TAS DEVICE

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.

Standard sizing valve in TAS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)
• Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
• Patients are technical and anatomical eligible for interventions

You may not qualify if:

• 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
• Subject refuses a blood transfusion.
• Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
• Native aortic annulus size \< 20 mm or \> 29 mm per the baseline diagnostic imaging.
• Life expectancy is less than one year

Sponsors & Collaborators

• Jian'an Wang,MD,PhD: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Jian-an Wang, MD,PhD

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianbao Liu, MD

CONTACT

+86-13857173887; liuxb2009@hotmail.com

Jian-an Wang, MD,PhD

CONTACT

+86-13805786328; Wang_jian_an@tom.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: September 4, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2023
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

CN (1)