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NCT05836493
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
trial testing Ring annuloplasty in Tricuspid Regurgitation in 146 participants. Completed in 23 October 2020.
23 October 2020
Quick facts
| Lead sponsor | Michele De Bonis |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 146 |
| Start date | 7 October 2020 |
| Primary completion | 23 October 2020 |
| Estimated completion | 23 October 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Ring annuloplasty
- Suture procedure
Conditions studied
- Tricuspid Regurgitation — all drugs for Tricuspid Regurgitation →
Sponsor
Michele De Bonis
Who can join
18 and older, any sex, with Tricuspid Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (\>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05836493
- 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.
- NCT07509658 — TriClip Japan Post-Approval Study · recruiting
- NCT07042360 — Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation · recruiting
- 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 Michele De Bonis trials
Trials by the same sponsor.
- NCT05774821 — Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term R · completed
- NCT05774808 — Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitat · completed
- NCT05721417 — Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging · completed
- NCT05774769 — Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time. · completed
- NCT05733988 — Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results · completed
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 NCT05836493 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Michele De Bonis
- Last refreshed: 1 May 2023
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/NCT05836493.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing