- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05497141
Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation
Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial (NoTR): A Trial to Evaluate the Safety and Effectiveness of Transcatheter Valve Edge-to-edge Repair System in Patients With Severe Tricuspid Regurgitation
To evaluate the safety and effectiveness of Dawneo Neoblazar® transcatheter tricuspid valve edge-to-edge repair system in patients with severe tricuspid regurgitation.
This is a prospective, multicenter, randomized, objective performance criteria trial. 98 patients who meet the inclusion criteria will be included in the study. This study will be conducted in in each site as run-in subjects. Subjects who meet the requirements and who voluntarily participate in the trial and sign the informed consent form, will be implanted with the Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:To evaluate the safety and effectiveness of Dawneo Neoblazar® transcatheter tricuspid valve edge-to-edge repair system in patients with severe tricuspid regurgitation.
CLINICAL INVESTIGATION POPULATION:Patients who are on echocardiographic evidence of severe tricuspid regurgitation.
CLINICAL INVESTIGATION DESIGN:This is a prospective, multicenter, single arm, objective performance criteria trial. 98 patients who meet the inclusion criteria will be included in the study. This study will be conducted in in each site as run-in subjects. Subjects who meet the requirements and who voluntarily participate in the trial and sign the informed consent form, will be implanted with the Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fujian
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Xiamen, Fujian, China, 361000
- Recruiting
- Xiamen Cardiovascular Hospital Xiamen University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects of age > 18 years;
- Subjects suffering from severe tricuspid regurgitation (TR≥3+), defined by TTE or TEE;
- Subject has symptoms with NYHA ≥ Class II-Iva, or at least one hospitalization for symptoms of heart failure during the past 12 months.
Subjects with two cardiac surgeons agreements of contraindications to surgery or high risk, who meets at least one of the following three conditions:
① Euroscore≥8%;
② Presence of 2 or more Frailty Index;
③ Presence of 2 or more organ insufficiencies。
- Subjects who's tricuspid valve anatomy are suitable for transcatheter valve edge-to-edge repairment as assessed.
- Subjects agreeing to the scheduled follow up requirements, who can understand the purpose of the clinical investigation, and sign voluntarily the informed consent form by themselves and/or the subject' legal guardians.
Exclusion Criteria:
- Pulmonary artery systolic pressure >70 mmHg measured by transthoracic echocardiography or right heart catheterization, or irreversible precapillary pulmonary hypertension;
- The presence of calcification in the grasping area of the tricuspid valve leaflets (including the anterior, septal, and posterior leaflets) that affects clamping, and the thickness of the tricuspid valve leaflets≥4mm;
- Severe tricuspid leaflet perforation, cleft or other lesions which preventing the implantation;
- Tricuspid valve leaflets coaptation gap >7mm
- Tricuspid stenosis as assessed by echocardiography (defined as tricuspid orifice area ≤1.0 cm2)
- LVEF≤20%;
- Refractory heart failure requiring advanced intervention (e.g., left ventricular assist device, heart transplantation, etc.) (ACC/AHA stage D heart failure);
- Myocardial infarction or unstable angina within 4 weeks;
- Untreated severe coronary artery stenosis requiring revascularization;
- Received percutaneous coronary intervention within 1 month prior to implantation;
- Severe and uncontrolled hypertension: SBP≥180mmHg or DBP≥110mmHg;
- Previously implantation of tricuspid valve, annuloplasty ring or accepted tricuspid valve repair surgery;
- Pacemaker leads or ICD leads that may affect implantation
- Complications of other cardiac diseases requiring surgical intervention;
- Tricuspid leaflet lesions due to rheumatic heart disease (e.g., leaflet grossness, thickening, poor compliance, etc.);
- Combined with moderate or severer aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation;
- Congenital Ebstein malformation;
- Presents of thrombus, vegetation, mass in the right heart system, femoral vein or inferior vena cava, etc.
- Hemorrhagic disease or hypercoagulable state;
- Contraindication or allergic reaction to dual antiplatelet agents and anticoagulants;
- Active infection requiring antibiotic treatment;
- Renal failure, requiring dialysis treatment;
- Severe terminal illness (e.g., cancer, etc.) with a life expectancy of less than 1 year;
- Pregnant, lactating women, women preparing to conceive or women of childbearing age with a positive HCG test (except for women whose medical history describes menopause);
- Subjects have not met the observed endpoint in other clinical studies in which they participated;
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tricuspid valve edge-to edge Repair group
Subjects who received Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System will be included in this arm
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Subjects who received Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System will be included in this arm.
The Neoblazar® is intended for reconstruction of the insufficient tricuspid valve through tissue tissue approximation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Implantation Success
Time Frame: 12 months
|
|
12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial Success
Time Frame: 1 week
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The device was successfully delivered to the target position and successfully released, and the delivery system was successfully withdrawn from the body without any detachment incident.
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1 week
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NYHA Functional Class
Time Frame: 30 days, 6 months, 12 months, annual for five years
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New York Heart Association functional class(NYHA).
Number of Improvement in NYHA classification is defined as a reduction in NYHA classification of at least 1 grade from baseline by Core Lab assessment.
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30 days, 6 months, 12 months, annual for five years
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Six-minute walk test
Time Frame: 30 days, 6 months, 12 months, annual for five years
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Change in distence(m) from baseline
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30 days, 6 months, 12 months, annual for five years
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Reduction in TR grade
Time Frame: 30 days, 6 months, 12 months, annual for five years
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Number of patients with reduction in TR from baseline by Core Lab assessment
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30 days, 6 months, 12 months, annual for five years
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Collaborators and Investigators
Investigators
- Principal Investigator: Nianguo Dong, Dr, Wuhan Xiehe Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022YLK17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Michele De BonisCompleted
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Clinical Trials on Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System
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Helios Klinikum PforzheimRecruitingRight Heart Failure | Tricuspid Regurgitation | Cardiac Remodeling, Ventricular | Cardiac Remodeling, AtrialGermany
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LMU KlinikumRecruitingHeart Failure | Valvular Heart Disease | Tricuspid RegurgitationGermany
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Istituto Auxologico ItalianoRecruitingTricuspid RegurgitationItaly
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Heart Center Leipzig - University HospitalRecruitingCongestive Heart Failure | Tricuspid RegurgitationGermany
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Shanghai Shenqi Medical Technology Co., LtdRecruiting
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University of BordeauxRecruitingCongenital Heart Disease | Tricuspid Regurgitation | Systemic Right VentricleFrance
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Enlight Medical Technologies (Shanghai) Co., LtdActive, not recruitingDegenerative Mitral Valve DiseaseChina
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Peijia Medical Technology (Suzhou) Co., Ltd.RecruitingMitral Regurgitation | Degenerative Mitral Valve DiseaseChina
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Annetine GelijnsNational Heart, Lung, and Blood Institute (NHLBI)RecruitingMitral Valve RegurgitationUnited States, Germany, United Kingdom, Canada
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Deutsches Herzzentrum MuenchenRecruitingMitral Valve Stenosis | Mitral Valve Regurgitation | Tricuspid Valve RegurgitationGermany