VitaFlowTM II Transcatheter Aortic Valve System Study

NCT03575039 | Unknown

• 1 other identifier: Valve-2018-01
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Rate of all-cause mortality at 12 months post implantation

  all-cause mortality including cardiovascular and non-cardiovascular

  12 months post implantation

Secondary Outcomes (18)

• Rate of Composite of all-cause mortality and disabling stroke

  at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post implantation

• Rate of stroke (disabling and non-disabling)

  at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post-implantation

• Initial success

  within 30 days post-implantation

• Recapture success rate (when attempted)

  at 1st day post-implantation

• Successful insertion

  at 1st day post-implantation

Study Arms (1)

Single arm clinical investigation

EXPERIMENTAL

Subjects in experimental group will be implanted the VitaFlow II Transcatheter Aortic Valve System.

Device: VitaFlow II Transcatheter Aortic Valve System

Interventions

VitaFlow II Transcatheter Aortic Valve System DEVICE

VitaFlow II Transcatheter Aortic Valve System contains a Valve stent -VitaFlow Aortic Valve, a Delivery system-VitaFlow II Delivery System and a Introducer set

Single arm clinical investigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of age \> 18 years
• Subjects suffering from severe aortic valve stenosis, including bicuspid and tricuspid valves, defined as follows:
• High-gradient aortic stenosis (mean pressure gradient across aortic valve \>40 mmHg or peak velocity ≥4.0 m/s.
• Subject has symptomatic valve stenosis presenting with NYHA ≥ Class II
• Subjects with a documented heart team agreement of increased surgical risk as described in the population
• ECG-gated multi-slice computed tomographic (MSCT) measurements determined an aortic annulus or supra-annular diameter ≥17 and ≤29mm. Findings of TTE, TEE and conventional aortography should be integrated in the anatomic assessment, when performed
• Patient deemed eligible by Centralised Case Review Committee (CRC) assessment recommends VitaFlow™ II Transcatheter Aortic Valve System implantation
• Subject can understand the purpose of the clinical investigation, has signed voluntary the informed consent form and is agreeing to the scheduled follow up requirements

You may not qualify if:

• Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter incompatible with a 19 to 22F OD delivery system with integrated sheath or 21 to 24F OD sheath)
• Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
• Non-calcific acquired aortic stenosis
• Native unicuspid aortic valve or congenital aortic abnormality (except for bicuspid aortic valve) not permitting TAVI
• Previous implantation of heart valve in any position
• Severe aortic regurgitation (\>3+)
• Severe mitral regurgitation (\>3+)
• Severe tricuspid regurgitation (\>3+)
• Severe left ventricular (LV) dysfunction (left ventricular ejection fraction \< 30%)
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Multi-vessel coronary artery disease with a Syntax score or residual Syntax score \> 22 and/or unprotected left main coronary artery.
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Untreated cardiac conduction disease in need of pacemaker implantation
• Uncontrolled atrial fibrillation (resting heart rate \> 120bpm)
• Active and/or suspicion of endocarditis or ongoing sepsis

Sponsors & Collaborators

• Shanghai MicroPort CardioFlow Medtech Co., Ltd.: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicolo Piazza

  Bern Unversity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ada Wang

CONTACT

86-021-38954600-7814; wanglu2@microport.comwajin

Andy Jin

CONTACT

86-021-38954600; wajin@microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 2, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2024
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share