Clinical trial NCT04815785: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Fu Wai Hospital, Beijing, China
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: West China Hospital
name: General Hospital of Shenyang Military Region
name: The Second Affiliated Hospital of Harbin Medical University
name: Second Xiangya Hospital of Central South University
First posted: 2021-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All-cause mortality at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Device success rate (Immediate after procedure)
timeFrame: Immediate after procedure
measure: Procedure success rate
timeFrame: 72 hours after procedure/prior to discharge
measure: Cardiac function improvement
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other outcomes:
measure: Product performance evaluation
timeFrame: Immediate after procedure
measure: Operative complication
timeFrame: Immediately after procedure
measure: The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
measure: Incidence of major adverse valve-related events (MAVREs) during the trial
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
measure: hemorrhage
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
measure: acute kidney injury
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
measure: Vascular Complications
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
measure: Other TAVI related complications
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
measure: Valvular function
timeFrame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Locations:
city: Suzhou
country: China
facility: Peiga Medical Technology (Suzhou) Co., Ltd
state: Jiangsu
Study officials:
References: