Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
Primary Purpose
Aortic Stenosis
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TaurusOne® transcatheter aortic valve replacement system
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
- Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
- Age ≥ 70 years;
- Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ≥ 4.0 m/s, or aortic-valve gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area < 0.8 cm2, or effective orifice area < 0.5 cm2/m2);
- Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
- Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) [13] *;
- Life expectancy after implantation of prosthetic valve is more than one year evaluated by the cardiac team (including at least two cardiac surgeons);
- Aortic annulus diameter ≥ 18 mm and ≤ 29 mm (measured by cardiac CT);
Ascending aorta diameter < 50 mm
*: If the patient meets any of the following criteria judged by a multidisciplinary cardiac team composed of cardiologists and cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two cardiovascular surgeons), the patient will be identified as unsuitable for conventional surgery (at least STS ≥ 8 points):
- Estimated risk of surgery-related death or disability > 50% within 1 year;
- ≥3 major organ damage that could not be improved by surgery;
- Obstacles related to surgical procedures judged as serious
Exclusion Criteria:
- Patients with bacteremia or toxemia;
- Previous endocarditis or active endocarditis;
- Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T) within 30 days;
- Any intracardiac mass, left ventricular or atrial thrombus, vegetation on echocardiography;
- Symptomatic atrial fibrillation that cannot be improved by drug therapy;
- Familial hypertrophic cardiomyopathy;
- Mitral or tricuspid valve insufficiency (grade II regurgitation or higher);
- Previous aortic valve graft (mechanical or bioprosthetic valve);
- Known allergies to contrast agents, aspirin, heparin, ticlopidine drugs, nitinol shape memory alloy, or bovine products;
- Known contraindications or allergies to anticoagulant regimens, or inability to use anticoagulants throughout the trial;
- Other serious diseases that may reduce life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.);
- Current substance abuse problems (e.g., alcohol, cocaine, heroin, etc.);
- Scheduled to undergo surgery that may result in protocol noncompliance or confounding in data interpretation.
- Cerebrovascular accident (CVA) in the past 6 months;
- Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (>70%);
- White blood cell count <3×109/L, platelet count <50×109/L;
- Hemoglobin < 90 g/L;
- Patients with severe coagulopathy;
- Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
- Abdominal or thoracic aortic aneurysm;
- Hepatic encephalopathy or acute active hepatitis;
- On dialysis or baseline creatinine level > 2.5 mg/dL (221 μ mol/L);
- Bleeding tendency or history of coagulation disease or refusal of blood transfusion;
- Patients with active peptic ulcer or active gastrointestinal (GI) bleeding;
- Patients with neurological diseases that seriously affect mobility and activities of daily living;
- Patients with mental illness or psychological disorders who are unable to communicate effectively;
- Patients who need emergency surgery for any reason;
- Patients who have participated in other drug or medical device clinical trials within 3 months prior to screening;
- Other conditions that make the patient ineligible to participate in this clinical trial in judgement of investigators
Sites / Locations
- Peiga Medical Technology (Suzhou) Co., Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A single set of test
Arm Description
The experimental apparatus consisted of artificial aortic valve, transporter and loading system
Outcomes
Primary Outcome Measures
All-cause mortality at 12 months
All-cause mortality
Secondary Outcome Measures
Device success rate (Immediate after procedure)
Successful delivery and release of vascular access and prosthetic aortic valve, and successful withdrawal of the delivery catheter
Accurate placement of prosthetic aortic valve at the anatomical site
Prosthetic aortic valve meets the desired requirements (mean valve gradient < 20 mm Hg or maximal flow velocity < 3 m/s; No severe prosthetic valve regurgitation or perivalvular leak)
Procedure success rate
A successful procedure is defined as successful implantation of the prosthetic aortic valve at the correct anatomical site 72 hours after the operation or before discharge without severe prosthetic valve regurgitation or perivalvular leak.
Cardiac function improvement
NYHA functional classification
Full Information
NCT ID
NCT04815785
First Posted
March 6, 2021
Last Updated
October 20, 2023
Sponsor
Peijia Medical Technology (Suzhou) Co., Ltd.
Collaborators
Fu Wai Hospital, Beijing, China, Second Affiliated Hospital, School of Medicine, Zhejiang University, West China Hospital, General Hospital of Shenyang Military Region, The Second Affiliated Hospital of Harbin Medical University, Second Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04815785
Brief Title
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
Official Title
A Multicenter, Prospective, Single-Arm, Objective Performance Criteria Study to Evaluate the Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
May 11, 2020 (Actual)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peijia Medical Technology (Suzhou) Co., Ltd.
Collaborators
Fu Wai Hospital, Beijing, China, Second Affiliated Hospital, School of Medicine, Zhejiang University, West China Hospital, General Hospital of Shenyang Military Region, The Second Affiliated Hospital of Harbin Medical University, Second Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.
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
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A single set of test
Arm Type
Experimental
Arm Description
The experimental apparatus consisted of artificial aortic valve, transporter and loading system
Intervention Type
Device
Intervention Name(s)
TaurusOne® transcatheter aortic valve replacement system
Intervention Description
The TaurusOne® Transcatheter Aortic Valve System consists of an aortic valve, an associated delivery catheter and a loading system. The aortic valve consists of a self-expanding nitinol frame, a sealing skirt and valve leaflets, which are made of bovine pericardium. The delivery system is mainly composed of conical head, opacity ring, inner tube, top ring, middle tube, outer tube, booster rod, stress diffusion catheter, handle, etc. The outflow end of the aortic valve is provided with three fixing holes evenly distributed on the circumference on the top ring of the delivery catheter, so as to facilitate the installation, delivery and release of the aortic valve. Before the operation, the aortic valve needs to be installed into the sheath of the delivery catheter as required.
Primary Outcome Measure Information:
Title
All-cause mortality at 12 months
Description
All-cause mortality
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Device success rate (Immediate after procedure)
Description
Successful delivery and release of vascular access and prosthetic aortic valve, and successful withdrawal of the delivery catheter
Accurate placement of prosthetic aortic valve at the anatomical site
Prosthetic aortic valve meets the desired requirements (mean valve gradient < 20 mm Hg or maximal flow velocity < 3 m/s; No severe prosthetic valve regurgitation or perivalvular leak)
Time Frame
Immediate after procedure
Title
Procedure success rate
Description
A successful procedure is defined as successful implantation of the prosthetic aortic valve at the correct anatomical site 72 hours after the operation or before discharge without severe prosthetic valve regurgitation or perivalvular leak.
Time Frame
72 hours after procedure/prior to discharge
Title
Cardiac function improvement
Description
NYHA functional classification
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other Pre-specified Outcome Measures:
Title
Product performance evaluation
Description
Product Performance includes grip loading, emptying , delivery, release, retrace, development and retrieval performance of delivery catheter system. Every item measured by:1=good 2=average 3=poor.
Time Frame
Immediate after procedure
Title
Operative complication
Description
The rate of operative complication
Time Frame
Immediately after procedure
Title
The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)
Description
Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Title
Incidence of major adverse valve-related events (MAVREs) during the trial
Description
including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction.
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Title
hemorrhage
Description
Rate of patients with hemorrhage during the trial.
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Title
acute kidney injury
Description
Rate of patients with acute kidney injury during the trial.
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Title
Vascular Complications
Description
Vascular Complications
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Title
Other TAVI related complications
Description
Rate of patients with Other TAVI related complications during the trial. Other TAVI related complications include conversion to surgery, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, pericardial tamponade, endocarditis, valvular thrombosis, valvular ectopic (displacement, embolization, erroneous release), etc.
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Title
Valvular function
Description
Valvular function include valve stenosis, valve regurgitation, valve function (such as opening area, pressure gradient), perivalvular leakage, etc.
There is Echo standard in VARC II to apply for valvular function assessment.
Time Frame
30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
Age ≥ 70 years;
Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ≥ 4.0 m/s, or aortic-valve gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area < 0.8 cm2, or effective orifice area < 0.5 cm2/m2);
Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) [13] *;
Life expectancy after implantation of prosthetic valve is more than one year evaluated by the cardiac team (including at least two cardiac surgeons);
Aortic annulus diameter ≥ 18 mm and ≤ 29 mm (measured by cardiac CT);
Ascending aorta diameter < 50 mm
*: If the patient meets any of the following criteria judged by a multidisciplinary cardiac team composed of cardiologists and cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two cardiovascular surgeons), the patient will be identified as unsuitable for conventional surgery (at least STS ≥ 8 points):
Estimated risk of surgery-related death or disability > 50% within 1 year;
≥3 major organ damage that could not be improved by surgery;
Obstacles related to surgical procedures judged as serious
Exclusion Criteria:
Patients with bacteremia or toxemia;
Previous endocarditis or active endocarditis;
Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T) within 30 days;
Any intracardiac mass, left ventricular or atrial thrombus, vegetation on echocardiography;
Symptomatic atrial fibrillation that cannot be improved by drug therapy;
Familial hypertrophic cardiomyopathy;
Mitral or tricuspid valve insufficiency (grade II regurgitation or higher);
Previous aortic valve graft (mechanical or bioprosthetic valve);
Known allergies to contrast agents, aspirin, heparin, ticlopidine drugs, nitinol shape memory alloy, or bovine products;
Known contraindications or allergies to anticoagulant regimens, or inability to use anticoagulants throughout the trial;
Other serious diseases that may reduce life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.);
Current substance abuse problems (e.g., alcohol, cocaine, heroin, etc.);
Scheduled to undergo surgery that may result in protocol noncompliance or confounding in data interpretation.
Cerebrovascular accident (CVA) in the past 6 months;
Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (>70%);
White blood cell count <3×109/L, platelet count <50×109/L;
Hemoglobin < 90 g/L;
Patients with severe coagulopathy;
Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
Abdominal or thoracic aortic aneurysm;
Hepatic encephalopathy or acute active hepatitis;
On dialysis or baseline creatinine level > 2.5 mg/dL (221 μ mol/L);
Bleeding tendency or history of coagulation disease or refusal of blood transfusion;
Patients with active peptic ulcer or active gastrointestinal (GI) bleeding;
Patients with neurological diseases that seriously affect mobility and activities of daily living;
Patients with mental illness or psychological disorders who are unable to communicate effectively;
Patients who need emergency surgery for any reason;
Patients who have participated in other drug or medical device clinical trials within 3 months prior to screening;
Other conditions that make the patient ineligible to participate in this clinical trial in judgement of investigators
Facility Information:
Facility Name
Peiga Medical Technology (Suzhou) Co., Ltd
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215025
Country
China
12. IPD Sharing Statement
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Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
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