Tricuspid RegurgitationNCT05497141
Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation
A study testing Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System in people with Tricuspid Regurgitation, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2022to 22 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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；
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- 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.
Who cannot join
- 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%；
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361000
Yan Wang, Ph.D, wy@medmail.com.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System
- Keywords
- sever tricuspid regurgitation, edge-to edge repair system, heart failure
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tricuspid valve edge-to edge Repair group | Experimental | Subjects who received Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System will be included in this arm Receives: Device: Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Implantation Success
- No all-cause mortality after implantation;
- No tricuspid open surgery after implantation;
- tricuspid regurgitation reduction at least 1 grade.
Measured: 12 months
Secondary outcomes (4)
Initial Success
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.
Measured: 1 week
NYHA Functional Class
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.
Measured: 30 days, 6 months, 12 months, annual for five years
Six-minute walk test
Change in distence(m) from baseline
Measured: 30 days, 6 months, 12 months, annual for five years
Reduction in TR grade
Number of patients with reduction in TR from baseline by Core Lab assessment
Measured: 30 days, 6 months, 12 months, annual for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start22 Jul 2022
- Primary completion22 Aug 2023 (estimated)
- Study completion22 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Dr, Principal investigator, Clinical Trial Center of Xiamen Cardiovascular HospitalNianguo Dong, Dr, Principal investigator, Wuhan Xiehe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497141
- Sponsor's protocol ID
- 2022YLK17
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05497141
- Acronym / sponsor ID
- 2022YLK17
- Conditions
- Tricuspid Regurgitation
- Keywords
- sever tricuspid regurgitation, edge-to edge repair system, heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen UniversityUniversity, hospital or other
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 22 Aug 2023 (estimated)
- Study completion
- 22 Oct 2023 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tricuspid valve edge-to edge Repair group | Experimental | Device: Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair SystemSubjects who received Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System will be included in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%；
Key exclusion criteria (26 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair SystemSubjects 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. | Device | tricuspid valve edge-to edge Repair group |
Primary outcome
Rate of Implantation Success
Time frame: 12 months
1. No all-cause mortality after implantation; 2. No tricuspid open surgery after implantation; 3. tricuspid regurgitation reduction at least 1 grade.
4 secondary outcomes
Initial Success
Time frame: 1 week
NYHA Functional Class
Time frame: 30 days, 6 months, 12 months, annual for five years
Six-minute walk test
Time frame: 30 days, 6 months, 12 months, annual for five years
Reduction in TR grade
Time frame: 30 days, 6 months, 12 months, annual for five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Wang, Dr principal investigator
Clinical Trial Center of Xiamen Cardiovascular Hospital
Nianguo Dong, Dr principal investigator
Wuhan Xiehe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System in people with Tricuspid Regurgitation, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site 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 9 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Chen, Dr (18033997788, Seanchenx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Implantation Success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2022.