Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation
China98 participantsStarted 2022-07-22
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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;
What they're measuring
1
Rate of Implantation Success
Timeframe: 12 months
Trial details
NCT IDNCT05497141
SponsorXiamen Cardiovascular Hospital, Xiamen University