NCT04744857

Brief Summary

The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

January 29, 2021

Last Update Submit

February 18, 2021

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Composite event rate at 30 days

    Patient-oriented composite event including all-cause death，severe stroke，myocardial infarction, permanent pacemaker implantation，surgical reoperation and valve-in-valve.

    30 days after procedure

Secondary Outcomes (4)

  • Device success rate (immediately after procedure)

    Immediately after procedure

  • Procedure success rate

    72 hours after procedure/prior to discharge

  • Cardiac function improvement

    30 days after procedure

  • Quality of life of patients

    30 days after procedure

Other Outcomes (8)

  • Product performance evaluation

    Immediately after procedure

  • operative complication

    Immediately after procedure

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

    30 days after procedure

  • +5 more other outcomes

Study Arms (1)

A single set of test

EXPERIMENTAL

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

Combination Product: The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.

Interventions

The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.COMBINATION_PRODUCT

Using the grip-loading system, the artificial aortic valve was squeezed and loaded into the sheath of the transporter through the vascular approach.The artificial aortic valve is delivered and positioned at the correct anatomical position for release. For example, the artificial main valve is displayed after partial release If the aortic valve is not in the correct anatomical position, the artificial aortic valve can be recovered and placed into the sheath tube of the transporter for re-positioning and release.

Also known as: The TaurusOne® transcatheter aortic valve replacement system features a retrievable delivery catheter system
A single set of test

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
  • Age ≥70 years old;
  • Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area \< 0.8cm2, or effective aortic valve orifice the product index is \< 0.5cm2/m2);
  • Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ or higher;
  • The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
  • The life expectancy of the patient after implantation of the prosthetic valve was evaluated by the cardiac team (at least two specialists in cardiovascular surgery) as more than one year;
  • Patients with aortic ring diameter ≥18mm and ≤29mm (cardiac CT measurement);
  • The diameter of the ascending aorta of the patient was \< 50mm.

You may not qualify if:

  • Patients with bacteremia or toxemia;
  • previous history or active endocarditis;
  • Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and/or troponin T) within 30 days;
  • Echocardiography found any intracardiac mass, left ventricle or atrial thrombosis, vegetations;
  • Symptomatic atrial fibrillation that cannot be improved by medication;
  • Familial hypertrophic cardiomyopathy;
  • Mitral valve and tricuspid valve insufficiency (reflux Ⅱ level above);
  • Prior aortic valve grafts (mechanical or biological valve stents);
  • Known allergy to contrast agent, aspirin, heparin, ticlopidine, nickel-titanium memory alloy, or bovine products;
  • Known to be contraindication or allergic to all anticoagulant regimens, or unable to use anticoagulant during the test;
  • Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.)
  • Current drug abuse problem (e.g., alcohol, cocaine, heroin, etc.); Plan to undergo surgery that may cause nonadherence to protocol or confusion in data interpretation.
  • Cerebrovascular accident (CVA) in the past 6 months;
  • Patients with common or internal carotid or vertebral artery stenosis (\> 70%);
  • WBC count \< 3×109/L, platelet count \< 50×109/ L;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peiga Medical Technology (Suzhou) Co., Ltd

Suzhou, Jiangsu, 215025, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Membrane Transport Proteins

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Carrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Preliminary data from the TaurusOne® clinical trial show good safety and efficacy in this trial without altering the artificial aorta To evaluate the safety and effectiveness of a transporter with a recoverable function. Take TaurusOne® in a clinical trial of compounding Endpoint event incidence was used as a target control.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 9, 2021

Study Start

December 13, 2019

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)