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

NCT04815785 | Unknown

• 1 other identifier: CSP12000-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 12 months

  All-cause mortality

  12 months

Secondary Outcomes (3)

• Device success rate (Immediate after procedure)

  Immediate after procedure

• Procedure success rate

  72 hours after procedure/prior to discharge

• Cardiac function improvement

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

Other Outcomes (9)

• Product performance evaluation

  Immediate after procedure

• Operative complication

  Immediately after procedure

• The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)

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

Study Arms (1)

A single set of test

EXPERIMENTAL

The experimental apparatus consisted of artificial aortic valve, transporter and loading system

Device: TaurusOne® transcatheter aortic valve replacement system

Interventions

TaurusOne® transcatheter aortic valve replacement system DEVICE

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.

A single set of test

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%);

Sponsors & Collaborators

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

Study Sites (1)

Peiga Medical Technology (Suzhou) Co., Ltd

Suzhou, Jiangsu, 215025, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 25, 2021
• Study Start: September 22, 2017
• Primary Completion: May 11, 2020
• Study Completion: May 30, 2024
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CN (1)