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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
Xiamen Cardiovascular Hospital, Xiamen University·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Tricuspid Regurgitation
Drug/Device/Intervention
Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Xiamen Cardiovascular Hospital, Xiamen University
Location
Xiamen, China
Timeline & enrollment
Phase
N/A
Start date
Jul 22, 2022
End date
Oct 22, 2023
Enrollment
98 participants
Primary outcome

Rate of Implantation Success

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.

ICD-10 classifications
Tricuspid stenosisTricuspid stenosis with insufficiencyNonrheumatic tricuspid (valve) stenosisTricuspid insufficiencyNonrheumatic tricuspid (valve) stenosis with insufficiency
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05497141
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05497141 through Pure Global AI's free database. This phase not specified trial is sponsored by Xiamen Cardiovascular Hospital, Xiamen University and is currently Recruiting. The study focuses on Tricuspid Regurgitation. Target enrollment is 98 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.