Last reviewed · How we verify
NCT05721417
Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
trial testing Tricuspid valve surgery in Tricuspid Regurgitation in 172 participants. Completed in 12 February 2022.
12 February 2022
Quick facts
| Lead sponsor | Michele De Bonis |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 172 |
| Start date | 1 February 2022 |
| Primary completion | 12 February 2022 |
| Estimated completion | 12 February 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Tricuspid valve surgery
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
Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension. Isolated tricuspid surgery has been performed for a long time in a few selected cases, however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself. To facilitate patient screening, a new clinical and functional TR staging system has recently been proposed. This classification, which evaluates the progression of morphological variations of the tricuspid valve and right ventricle (RV) in association with the onset of symptoms, identifies several parameters and factors that can be useful for a better stratification of surgical risk. Rather than simply assessing the degree of TR, this new staging mechanism also focuses on symptoms, RV remodeling and function, medical therapy, and right heart failure hospitalizations. Investigators previously focused on the short-term (mainly hospital) outcomes of patients undergoing isolated surgery for severe TR, who were classified at baseline according to this clinical and functional staging system. Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR. The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes.
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 NCT05721417
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tricuspid valve surgery
Trials testing the same drug.
- NCT05774821 — Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term R · completed
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
- 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
- NCT05774795 — LOng-Term Fate of Moderate Aortic Regurgitation Left Untreated at the Time of Mitral Valve Surgery · 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 NCT05721417 (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: 10 February 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/NCT05721417.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing