Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: TaurusOne® transcatheter aortic valve replacement system

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215025
      • Peiga Medical Technology (Suzhou) Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A single set of test; The experimental apparatus consisted of artificial aortic valve, transporter and loading system

Device: TaurusOne® transcatheter aortic valve replacement system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 12 months	All-cause mortality	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Immediate after procedure
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.	72 hours after procedure/prior to discharge
Cardiac function improvement	NYHA functional classification	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative complication	The rate of operative complication	Immediately after procedure
The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)	Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Incidence of major adverse valve-related events (MAVREs) during the trial	including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Product performance evaluation	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.	Immediate after procedure
hemorrhage	Rate of patients with hemorrhage during the trial.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
acute kidney injury	Rate of patients with acute kidney injury during the trial.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Vascular Complications	Vascular Complications	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other TAVI related complications	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.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Valvular function	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.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

Collaborators and Investigators

• Sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.
• Collaborators: General Hospital of Shenyang Military Region; West China Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; The Second Affiliated Hospital of Harbin Medical University; Second Xiangya Hospital of Central South University; Fu Wai Hospital, Beijing, China

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): May 11, 2020
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: March 6, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: CSP12000-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No