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NCT05774769
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
trial testing Commissural edge to edge mitral valve repair in Degenerative Mitral Valve Disease in 125 participants. Completed in 19 October 2021.
19 October 2021
Quick facts
| Lead sponsor | Michele De Bonis |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 125 |
| Start date | 9 October 2021 |
| Primary completion | 19 October 2021 |
| Estimated completion | 19 October 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Commissural edge to edge mitral valve repair
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
Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.
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 NCT05774769
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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
- 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 NCT05774769 (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: 20 March 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/NCT05774769.
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