Back to resultsVitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
Primary Purpose
Aortic Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
VitaFlow™ II Transcatheter Aortic Valve System
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
- Age≥70 years;
- Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area<0.8cm² (or EOA index<0.5cm²/m²);
- NYHA≥II class;
- Estimated life-expectancy>12 months after implantation of the prosthetic valve;
- Anatomically suitable for the transcatheter aortic valve implantation procedure;
- The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Exclusion Criteria:
- Acute myocardial infarction (MI) in last 30 days before the treatment;
- Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
- Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
- Previous implantation of heart valve at any position；
- Hemodynamic instability requiring mechanical hemodynamic support devices;
- Need for emergency surgery for any reason;
- Hypertrophic cardiomyopathy with obstruction;
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction;
- Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
- Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
- Congenital aortic valve stenosis or unicuspid aortic valve;
- Vascular diseases or anatomical condition preventing the device access;
- Active endocarditis or other active infections at the time of treatment;
- Participating in another trial and the primary endpoint is not achieved.
- Inability to comply with the clinical investigation follow-up or other requirements.
Sites / Locations
- Fuwai HospitalRecruiting
- Zhongshan HospitalRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm clinical investigation
Arm Description
Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System
Outcomes
Primary Outcome Measures
Rate of all-cause mortality at 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
Secondary Outcome Measures
Valve function-mean prosthetic valve gradient
Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Valve function- effective orifice area
Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)
Valve function- degree of prosthetic valve regurgitation
Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
Rate of safety events according to VARC2
Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, conduction disturbance and arrhythmias, and new permanent pacemaker implantation
Rate of other TAVI-related complications
Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, and TAV-in-TAV
Rate of major adverse cardiac and cerebrovascular events(MACCE)
Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances
Rate of device success
Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function
Rate of balloon pre-dilation success
Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter
Rate of balloon post-dilation success
Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter
Rate of procedure success
Rate of procedure success, assessed by the device success and the peri-procedural complications
Full Information
NCT ID
NCT04414878
First Posted
May 27, 2020
Last Updated
May 31, 2020
Sponsor
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04414878
Brief Title
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
Official Title
A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2027 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Detailed Description
This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic 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
145 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm clinical investigation
Arm Type
Experimental
Arm Description
Subjects in experimental group will be implanted with 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™ Delivery System, loading tools, and a guide-wire
Primary Outcome Measure Information:
Title
Rate of all-cause mortality at 12 months post implantation
Description
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
Time Frame
12 months post implantation
Secondary Outcome Measure Information:
Title
Valve function-mean prosthetic valve gradient
Description
Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Time Frame
at 30 days, 6 months, and 1 year post implantation
Title
Valve function- effective orifice area
Description
Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)
Time Frame
at 30 days, 6 months, and 1 year post implantation
Title
Valve function- degree of prosthetic valve regurgitation
Description
Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
Time Frame
at 30 days, 6 months, and 1 year post implantation
Title
Rate of safety events according to VARC2
Description
Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, conduction disturbance and arrhythmias, and new permanent pacemaker implantation
Time Frame
at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Title
Rate of other TAVI-related complications
Description
Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, and TAV-in-TAV
Time Frame
at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Title
Rate of major adverse cardiac and cerebrovascular events(MACCE)
Description
Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances
Time Frame
at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Title
Rate of device success
Description
Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function
Time Frame
at immediate post implantation
Title
Rate of balloon pre-dilation success
Description
Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter
Time Frame
at immediate post implantation
Title
Rate of balloon post-dilation success
Description
Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter
Time Frame
at immediate post implantation
Title
Rate of procedure success
Description
Rate of procedure success, assessed by the device success and the peri-procedural complications
Time Frame
at immediate post implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥70 years;
Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area<0.8cm² (or EOA index<0.5cm²/m²);
NYHA≥II class;
Estimated life-expectancy>12 months after implantation of the prosthetic valve;
Anatomically suitable for the transcatheter aortic valve implantation procedure;
The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Exclusion Criteria:
Acute myocardial infarction (MI) in last 30 days before the treatment;
Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
Previous implantation of heart valve at any position；
Hemodynamic instability requiring mechanical hemodynamic support devices;
Need for emergency surgery for any reason;
Hypertrophic cardiomyopathy with obstruction;
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction;
Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
Congenital aortic valve stenosis or unicuspid aortic valve;
Vascular diseases or anatomical condition preventing the device access;
Active endocarditis or other active infections at the time of treatment;
Participating in another trial and the primary endpoint is not achieved.
Inability to comply with the clinical investigation follow-up or other requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bi Jie
Phone
(86)(21)38954600
Email
jbi@microport.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhujun Cai, PhD
Phone
(86)(21)38954600
Email
zjcai@microport.com
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongjian Wu, Prof
Phone
13701387189
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, Prof
Phone
13901977506
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mao Chen, Prof
Phone
18980602046
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-An Wang, Prof
Phone
13805786328
12. IPD Sharing Statement
Learn more about this trial
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
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