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NCT05497141
Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation
NA trial testing Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System in Tricuspid Regurgitation in 98 participants. Status unknown.
22 August 2023
Quick facts
| Lead sponsor | Xiamen Cardiovascular Hospital, Xiamen University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 22 July 2022 |
| Primary completion | 22 August 2023 |
| Estimated completion | 22 October 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System
Conditions studied
- Tricuspid Regurgitation — all drugs for Tricuspid Regurgitation →
Sponsor
Xiamen Cardiovascular Hospital, Xiamen University
Who can join
18 and older, any sex, with Tricuspid Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tricuspid Transcatheter Edge-to-Edge Repair at a Crossroads: Prognosis-Shaping Intervention or High-Tech Palliation?
Mitsis A, Ioannides M, Rotos C, Kadoglou NPE, et al · · 2026 · PMID 41598381 · DOI 10.3390/jcm15020443
Verify or expand the search:
- PubMed search for NCT05497141
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Tricuspid Regurgitation
Currently open trials in the same condition.
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- NCT06833476 — TTVR STRONG Under Coverage With Evidence Development (CED) Study · recruiting
- NCT06836011 — A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, a · recruiting
- NCT07085650 — The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation · recruiting
Other Xiamen Cardiovascular Hospital, Xiamen University trials
Trials by the same sponsor.
- NCT07055919 — Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER). · NA · recruiting
- NCT06532838 — Optimized Strategies for Malperfusion Syndrome · NA · not yet recruiting
- NCT05925335 — The China Mviv Registry · NA · unknown
- NCT04918030 — STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（ · NA · completed
- NCT05517356 — Prospective Study of Tailored Management Strategies for Malperfusion Syndrome · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05497141 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xiamen Cardiovascular Hospital, Xiamen University
- Last refreshed: 11 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05497141.
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