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Aortic RegurgitationNCT06101888

Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)

A study testing TaurusTrio™ Heart Valve System in people with Aortic Regurgitation, run by Peijia Medical Technology (Suzhou) Co., Ltd. at 19 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Regurgitation
What is being tested?
TaurusTrio™ Heart Valve System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
19 sitesChina
Study dates
1 Aug 2023to 31 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
  • Age ≥ 18 years;
  • Adult subjects with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric approach with:
  • Jet width ≥ 65% of LVOT
  • Vena contracta width of > 6 mm
  • Holodiastolic flow reversal in proximal abdominal/descending aorta
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  • Jet deceleration rate/Pressure half time <200ms
  • AND, For Grade 3:
  • Regurgitant volume ≥ 45-59 ml/beat
  • Regurgitant fraction ≥ 40-49%
  • EROA ≥ 0.2-0.29 cm2
  • OR, For Grade 4:
  • Regurgitant volume ≥ 60 ml/beat
  • Regurgitant fraction≥50%
  • EROA ≥ 0.3 cm2 Note: In cases where not all criteria listed for severe AR are met, the Core Lab will determine severity. Supplemental CMR imaging may be used to substantiate the degree of AR reported by Core Lab on baseline echo when imaging is suboptimal, Doppler parameters are discordant or inconclusive regarding the severity of AR, or when a discrepancy is present between the echo findings and the clinical setting.
  • Patients who have symptoms obviously caused by Aortic Regurgitation, such as dyspnea, chest pain, NYHA Class II or higher;
  • Patients who are unsuitable for conventional surgery but needs TAVR（It is recommended to refer to the 2020 ACC/AHA Heart Valve Disease Management Guidelines when evaluating the risks of surgical valve surgery），evaluated by the cardiac team (including at least one interventional cardiologist and one cardiovascular surgeon)
  • Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System，evaluated by core laboratory;

Who cannot join

  • Congenital uni- or bicuspid aortic valve morphology；
  • Previous prosthetic aortic valve (bioprosthesis or mechanical) implant；
  • Mitral regurgitation or Tricuspid regurgitation> moderate；
  • Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure；
  • Echocardiographic evidence of left ventricular thrombus；
  • Endocarditis within 180 days prior to index procedure；
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  • Hypertrophic cardiomyopathy with or without obstruction；
  • Severe pulmonary hypertension (systolic PA pressure >80 mmHg)；
  • Severe RV dysfunction as assessed clinically and by echo；
  • Severely reduced left ventricular ejection fraction (LVEF <25%)；
  • Aortic annular perimeter derived diameter of <21.0 mm or > 28.6 mm or perimeter <66.0 mm or >90 mm (assessed by Multi-Detector CT measurement)；
  • Aortic annulus angulation > 70° (assessed by Multi-Detector CT measurement)；
  • Straight length of ascending aorta of < 55 mm；
  • Significant disease of ascending aorta, including ascending aortic aneurysm ； (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick [>5 mm], protruding or ulcerated)
  • Need for urgent or emergent TAVR procedure for any reason；
  • Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device within 30 days prior to index procedure；
  • Myocardial infarction < 30 days prior to index procedure；
  • Cerebrovascular event (TIA, stroke) < 180 days prior to index procedure；
  • Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (>70%)；
  • Patients with severe coagulopathy；
  • Severe renal insufficiency (GFR < 30 ml/min) at Screening, OR renal disease requiring renal replacement therapy within 180 days prior to index procedure；
  • Blood dyscrasias as defined: leukopenia (WBC < 3000/mm³), or thrombocytopenia (platelets < 90,000/µl) or anemia (Men: Hgb < 8.1 g/dl; Women: Hgb < 7.4 g/dl)；
  • Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to index procedure；
  • Known allergies to to heparin, aspirin, ticlopidine, Clopidogrel, Nitroglycerin and other drugs，contrast agents, nitinol shape memory alloy, tantalum or porcine products；
  • Contraindication to intraoperative transesophageal echocardiography and/or Multi-Detector CT (MDCT) scan；
  • Estimated life-expectancy of < 24 months；
  • Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study);
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from providing appropriate informed consent;
  • Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments);
  • Unable to comply with follow-up requirements;

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

jing ren contact

18550112597

renjing@peijiamedical.com

19 sites in 1 country

China19 sites, 19 recruiting

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 215025

    guangyuan Song

    Recruiting

  • Fu Wai Hospital, Beijing, China

    Beijing, Beijing Municipality

    yongjian Wu

    Recruiting

  • Second Xiangya Hospital of Central South University

    Changsha, Hunan

    shenghua Zhou

    Recruiting

  • West China Hospital

    Chengdu, Sichuan

    mao chen

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    lianglong chen

    liangwan chen

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangdong, Guangzhou

    jiancheng Xiu

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    jianfang Luo

    Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Haerbin, Heilongjiang

    bo Yu

    Recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    jianan Wang

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang

    Hangzhou, Zhejiang

    guosheng Fu

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    guipeng An

    xinghua Gu

    Recruiting

  • The First Affiliated Hospital of Namchang Umiversity

    Nanchang, Jiangxi

    xiaoping Peng

    Recruiting

  • Nanjing First Hospital

    Nanjing, Jiangsu

    shaoliang Chen

    Recruiting

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality

    junbo Ge

    Recruiting

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning

    yaling Han

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    hong Jiang

    Recruiting

  • Wuhan Union Hospital, China

    Wuhan, Hubei

    xiang Cheng

    Recruiting

  • XiaMen Cardiovascular Hospital XiaMen University

    Xiamen, Fujian

    yan Wang

    Recruiting

  • Xijing Hospital

    Xian, Shanxi

    jian Yang

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation

To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Being tested
TaurusTrio™ Heart Valve System
Medical subject headings
Aortic Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TaurusTrio™ Heart Valve SystemDevice

    The TaurusTrio™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.

Study groups in NCT06101888
Study groupRoleWhat they receive
A single set of testExperimentalThe experimental apparatus consisted of TaurusTrio™ Heart Valve (THV), Delivery Catheter \& Introducer Sheath ,Loading Tools
Receives: Device: TaurusTrio™ Heart Valve System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality at 12 months

    All-cause mortality

    Measured: 12 months

Secondary outcomes (2)

  1. Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).

    Improvement in quality of life (QoL)

    Measured: 12 months

  2. Composite safety endpoint at 30 days

    all-cause death；all stroke； life-threatening or major bleeding；acute kidney injury (AKI) stage 2, 3 or dialysis；major vascular complications；surgery/intervention related to the device (including coronary intervention)；permanent pacemaker implantation；moderate or severe total aortic regurgitation

    Measured: 30 days after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2023
  2. Study start1 Aug 2023
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06101888
Sponsor's protocol ID
15CSP001
Status last verified
Mar 2024
First submitted
20 Oct 2023
Last updated
18 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing TaurusTrio™ Heart Valve System in people with Aortic Regurgitation, run by Peijia Medical Technology (Suzhou) Co., Ltd. at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jing ren (18550112597, renjing@peijiamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06101888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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