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VitaFlowTM II Transcatheter Aortic Valve System Study

Primary Purpose

Aortic Valve Stenosis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

VitaFlow II Transcatheter Aortic Valve System

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Blood dyscrasias defined as: leukopenia (WBC<1000 mm3), thrombocytopenia (PLT<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before signing informed consent
Any need for emergency surgery
Recent (within 6 months of signing informed consent) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days prior to signing informed consent
Any active bleeding that precludes anticoagulation
Liver failure (Child-C)
End-stage renal disease requiring chronic dialysis or creatinine clearance < 20cc/min
Pulmonary hypertension (systolic pressure >80mmHg)
Severe chronic pulmonary disease (COPD) demonstrated by an expiratory volume (FEV1) < 750cc
Refusal of blood transfusion
A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow up procedures
Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
Estimated life expectancy of less than 12 months
For female - pregnancy or intention to become pregnant prior to completion of all follow up procedures
Inability to comply with the clinical investigation follow-up or other clinical investigation requirements

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm clinical investigation

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of all-cause mortality at 12 months post implantation

all-cause mortality including cardiovascular and non-cardiovascular

Secondary Outcome Measures

Rate of Composite of all-cause mortality and disabling stroke

defined as the ratio of all-cause dead and disabled subjects to total subjects at each time point

Rate of stroke (disabling and non-disabling)

defined as the ratio of stroke subjects (disabling and non-disabling) to total subjects at each time point

Initial success

defined as absence of procedural mortality AND correct positioning of a single VitaFlowTM Aortic Valve into the proper anatomical location AND absence of patient / VitaFlowTM Aortic Valve mismatch AND mean aortic valve gradient less than (<) 20 mmHg or peak velocity less than (<) 3m/s, AND absence of moderate or severe prosthetic valve regurgitation

Recapture success rate (when attempted)

defined as VitaFlowTM Aortic Valve is fully re-sheathed into the VitaFlowTM II delivery system, as verified by fluoroscopy

Successful insertion

navigation and functioning of ALL features for the VitaFlowTM II delivery system, deployment and implantation of the VitaFlowTM aortic valve and subsequent retrieval of the VitaFlowTM II delivery system

Valve function

Evaluating valva function(including valve position, morphology, function and rate of valvular stenosis, valve regurgitation, orifice area and pressure gradient and paravalvular leakage) at each time point.

Changes in quality of life KCCQ

an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Changes in quality of life EQ-5D-5L

Use the questions and score system to evaluate life quality of subjects at each The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

Changes in frailty (KATZ questionnaire)

Assesses the ability of patients to conduct activities of daily living by questions in KATZ questionnaire. We use dependent(0 points) and independent(1 points) to evaluate bathing, dressing, toileting, transferring, contience and feeding activities of subjects. Total score is 6 points, the higher the score, the more indepent of subjects.

Changes in cardiac function

defined as changes in cardiac function at each time point according to the NYHA Classification Scheme compared to baseline

Rate of all-cause mortality

all-cause mortality including cardiovascular and non-cardiovascular

Rate of main adverse cardiac and cerebral events (MACCE)

Rate of main adverse cardiac and cerebral events (MACCE) including disabling stroke, myocardial infarction, open surgery, and new permanent pacemaker at each time point

Rate of life-threatening, disabling or severe bleeding (BARC 3 to 5)

BARC 3 to 5 defined as in BARC definition in annex of the protocol

Rate of acute kidney injury network stage 2 and 3 or renal alternation therapy

renal alternation therapy including haemodialysis, peritoneal dialysis and hemofiltration

Rate of implant related new and/or worsened conduction disturbances and arrhythmias, and occurrence of new permanent pacemaker implantation

Rate of major vascular complications

vascular complications defined according to VARC2 definitions

Rate of the occurrence of hospitalization

Rate of the occurrence of hospitalization for valve-related symptoms or worsening congestive heart failure

Rate of other TAVI-related adverse events

Rate of other TAVI-related adverse events (conversion to open surgery, unplanned used of cardiopulmonary bypass, coronary obstruction requiring intervention, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, TAV-in-TAV deployment, structural valve deterioration, valve related dysfunction or events requiring repeat procedure [BAV, TAVR, SAVR]

Full Information

NCT ID

NCT03575039

First Posted

May 31, 2018

Last Updated

June 29, 2018

Sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03575039

Brief Title

VitaFlowTM II Transcatheter Aortic Valve System Study

Official Title

The VITALE Study Evaluating Safety and Effectiveness/Performance of the Microport CardioFlow VitaFlow II - Transcatheter Aortic Valve System

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2018 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

Detailed Description

This is a prospective, multicenter, single arm and controlled clinical investigation compared to recent historical results. The purpose is to evaluate the safety, performance and efficacy of the VitaflowTM II Transcatheter Aortic Valve system. The entire system including valve system, delivery system and introducer system. We will implant the valve system into subjects and followed up them for 5 years after the procedure. This clinical trial will be conducted in 15 sites in Europe.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm clinical investigation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

VitaFlow II Transcatheter Aortic Valve System

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of all-cause mortality at 12 months post implantation

Description

all-cause mortality including cardiovascular and non-cardiovascular

Time Frame

12 months post implantation

Secondary Outcome Measure Information:

Title

Rate of Composite of all-cause mortality and disabling stroke

Description

defined as the ratio of all-cause dead and disabled subjects to total subjects at each time point

Time Frame

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

Title

Rate of stroke (disabling and non-disabling)

Description

defined as the ratio of stroke subjects (disabling and non-disabling) to total subjects at each time point

Time Frame

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

Title

Initial success

Description

Time Frame

within 30 days post-implantation

Title

Recapture success rate (when attempted)

Description

defined as VitaFlowTM Aortic Valve is fully re-sheathed into the VitaFlowTM II delivery system, as verified by fluoroscopy

Time Frame

at 1st day post-implantation

Title

Successful insertion

Description

Time Frame

at 1st day post-implantation

Title

Valve function

Description

Time Frame

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

Title

Changes in quality of life KCCQ

Description

Time Frame

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

Title

Changes in quality of life EQ-5D-5L

Description

Time Frame

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

Title

Changes in frailty (KATZ questionnaire)

Description

Time Frame

at 30 days, 12 months, 1, 2, 3, 4 and 5 years post-implantation compared to baseline

Title

Changes in cardiac function

Description

defined as changes in cardiac function at each time point according to the NYHA Classification Scheme compared to baseline

Time Frame

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

Title

Rate of all-cause mortality

Description

all-cause mortality including cardiovascular and non-cardiovascular

Time Frame

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

Title

Rate of main adverse cardiac and cerebral events (MACCE)

Description

Rate of main adverse cardiac and cerebral events (MACCE) including disabling stroke, myocardial infarction, open surgery, and new permanent pacemaker at each time point

Time Frame

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

Title

Rate of life-threatening, disabling or severe bleeding (BARC 3 to 5)

Description

BARC 3 to 5 defined as in BARC definition in annex of the protocol

Time Frame

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

Title

Rate of acute kidney injury network stage 2 and 3 or renal alternation therapy

Description

renal alternation therapy including haemodialysis, peritoneal dialysis and hemofiltration

Time Frame

at 30 days, 6 and 12 months and 2 to 5 years

Title

Rate of implant related new and/or worsened conduction disturbances and arrhythmias, and occurrence of new permanent pacemaker implantation

Description

Rate of implant related new and/or worsened conduction disturbances and arrhythmias, and occurrence of new permanent pacemaker implantation

Time Frame

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

Title

Rate of major vascular complications

Description

vascular complications defined according to VARC2 definitions

Time Frame

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

Title

Rate of the occurrence of hospitalization

Description

Rate of the occurrence of hospitalization for valve-related symptoms or worsening congestive heart failure

Time Frame

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

Title

Rate of other TAVI-related adverse events

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Blood dyscrasias defined as: leukopenia (WBC<1000 mm3), thrombocytopenia (PLT<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states Evidence of an acute myocardial infarction ≤ 1 month (30 days) before signing informed consent Any need for emergency surgery Recent (within 6 months of signing informed consent) cerebrovascular accident (CVA) or transient ischemic attack (TIA) Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days prior to signing informed consent Any active bleeding that precludes anticoagulation Liver failure (Child-C) End-stage renal disease requiring chronic dialysis or creatinine clearance < 20cc/min Pulmonary hypertension (systolic pressure >80mmHg) Severe chronic pulmonary disease (COPD) demonstrated by an expiratory volume (FEV1) < 750cc Refusal of blood transfusion A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow up procedures Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed Estimated life expectancy of less than 12 months For female - pregnancy or intention to become pregnant prior to completion of all follow up procedures Inability to comply with the clinical investigation follow-up or other clinical investigation requirements

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ada Wang

Phone

86-021-38954600-7814

wanglu2@microport.comwajin

First Name & Middle Initial & Last Name or Official Title & Degree

Andy Jin

Phone

86-021-38954600

wajin@microport.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolo Piazza

Organizational Affiliation

Bern Unversity Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This is an internal clinical research, the detail data won't be shared with other researcher before our product come into the market.

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VitaFlowTM II Transcatheter Aortic Valve System Study

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