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Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation - Trial NCT05497141

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.

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Trial Details
ClinicalTrials.govNCT05497141
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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

Study Focus

Tricuspid Regurgitation

Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System

Interventional

device

Sponsor & Location

Xiamen Cardiovascular Hospital, Xiamen University

Xiamen, China

Timeline & Enrollment

N/A

Jul 22, 2022

Oct 22, 2023

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 stenosis
Tricuspid stenosis with insufficiency
Nonrheumatic tricuspid (valve) stenosis
Tricuspid insufficiency
Nonrheumatic tricuspid (valve) stenosis with insufficiency

Data Source

ClinicalTrials.gov

NCT05497141

Device Trial