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NCT05839782
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
trial testing Mitral valve repair (PLM) in Degenerative Mitral Valve Disease in 108 participants. Completed in 15 October 2019.
15 October 2019
Quick facts
| Lead sponsor | Michele De Bonis |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 108 |
| Start date | 5 October 2019 |
| Primary completion | 15 October 2019 |
| Estimated completion | 15 October 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Mitral valve repair (PLM)
- Mitral valve replacement
Conditions studied
- Degenerative Mitral Valve Disease — all drugs for Degenerative Mitral Valve Disease →
Sponsor
Michele De Bonis
Who can join
18 and older, any sex, with Degenerative Mitral Valve Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis. However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years. Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.
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 NCT05839782
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Degenerative Mitral Valve Disease
Currently open trials in the same condition.
- NCT05655897 — Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or · NA · recruiting
- NCT06021509 — Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation · NA · active not recruiting
- NCT05595226 — Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease · NA · recruiting
- NCT03706833 — Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial · NA · active not recruiting
- NCT03674593 — Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae · NA · active not 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 NCT05839782 (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: 3 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/NCT05839782.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing