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

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

Interventional

Enrollment (Anticipated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Xiamen Cardiovascular Hospital Xiamen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects of age > 18 years;
  2. Subjects suffering from severe tricuspid regurgitation (TR≥3+), defined by TTE or TEE;
  3. Subject has symptoms with NYHA ≥ Class II-Iva, or at least one hospitalization for symptoms of heart failure during the past 12 months.
  4. 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。

  5. Subjects who's tricuspid valve anatomy are suitable for transcatheter valve edge-to-edge repairment as assessed.
  6. 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:

  1. Pulmonary artery systolic pressure >70 mmHg measured by transthoracic echocardiography or right heart catheterization, or irreversible precapillary pulmonary hypertension;
  2. 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;
  3. Severe tricuspid leaflet perforation, cleft or other lesions which preventing the implantation;
  4. Tricuspid valve leaflets coaptation gap >7mm
  5. Tricuspid stenosis as assessed by echocardiography (defined as tricuspid orifice area ≤1.0 cm2)
  6. LVEF≤20%;
  7. Refractory heart failure requiring advanced intervention (e.g., left ventricular assist device, heart transplantation, etc.) (ACC/AHA stage D heart failure);
  8. Myocardial infarction or unstable angina within 4 weeks;
  9. Untreated severe coronary artery stenosis requiring revascularization;
  10. Received percutaneous coronary intervention within 1 month prior to implantation;
  11. Severe and uncontrolled hypertension: SBP≥180mmHg or DBP≥110mmHg;
  12. Previously implantation of tricuspid valve, annuloplasty ring or accepted tricuspid valve repair surgery;
  13. Pacemaker leads or ICD leads that may affect implantation
  14. Complications of other cardiac diseases requiring surgical intervention;
  15. Tricuspid leaflet lesions due to rheumatic heart disease (e.g., leaflet grossness, thickening, poor compliance, etc.);
  16. Combined with moderate or severer aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation;
  17. Congenital Ebstein malformation;
  18. Presents of thrombus, vegetation, mass in the right heart system, femoral vein or inferior vena cava, etc.
  19. Hemorrhagic disease or hypercoagulable state;
  20. Contraindication or allergic reaction to dual antiplatelet agents and anticoagulants;
  21. Active infection requiring antibiotic treatment;
  22. Renal failure, requiring dialysis treatment;
  23. Severe terminal illness (e.g., cancer, etc.) with a life expectancy of less than 1 year;
  24. 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);
  25. Subjects have not met the observed endpoint in other clinical studies in which they participated;
  26. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Success
Time Frame: 1 week
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.
1 week
NYHA Functional Class
Time Frame: 30 days, 6 months, 12 months, annual for five years
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.
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
Change in distence(m) from baseline
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
Number of patients with reduction in TR from baseline by Core Lab assessment
30 days, 6 months, 12 months, annual for five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nianguo Dong, Dr, Wuhan Xiehe Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Anticipated)

August 22, 2023

Study Completion (Anticipated)

October 22, 2023

Study Registration Dates

First Submitted

August 7, 2022

First Submitted That Met QC Criteria

August 8, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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