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NCT05850026
Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
trial testing Septal myectomy and mitral valve repair with edge-to-edge technique in Hypertrophic Obstructive Cardiomyopathy in 26 participants. Completed in 15 October 2019.
15 October 2019
Quick facts
| Lead sponsor | Michele De Bonis |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 26 |
| Start date | 5 October 2019 |
| Primary completion | 15 October 2019 |
| Estimated completion | 15 October 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Septal myectomy and mitral valve repair with edge-to-edge technique
Conditions studied
- Hypertrophic Obstructive Cardiomyopathy — all drugs for Hypertrophic Obstructive Cardiomyopathy →
- Mitral Regurgitation — all drugs for Mitral Regurgitation →
Sponsor
Michele De Bonis
Who can join
18 and older, any sex, with Hypertrophic Obstructive Cardiomyopathy or Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Septal myectomy is performed in selected cases to treat patients with hypertrophic obstructive cardiomyopathy (HOCM). The mechanism that causes obstruction involves both the outflow tract itself and the mitral apparatus, with the appearance of mitral regurgitation (MR) by SAM (Systolic Anterior Motion). When the interventricular septum is not particularly thick, isolated myectomy may not be sufficient to eliminate the SAM; in these cases the concomitant treatment of the mitral valve is considered. Different approaches have been proposed: mitral replacement with prosthesis, plication or lengthening of the anterior leaflet or the edge-to-edge (EE) technique. In addition, a small proportion of patients with HOCM may have MR from organic valve abnormalities, requiring specific treatment. Currently, there are few studies in the literature aimed at determining the role of EE in the context of HOCM; most of these studies are characterized by short follow-up or by the scarcity of echocardiographic data. The aim of the present study is to evaluate the long-term outcomes of EE associated with septal myectomy in patients with CMIO, both from a clinical point of view and by reporting echocardiographic data.
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 NCT05850026
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypertrophic Obstructive Cardiomyopathy
Currently open trials in the same condition.
- NCT05332691 — Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy · NA · recruiting
- NCT05257772 — Electromechanically Optimised Right Ventricular Pacing In Hypertrophic Cardiomyopathy (EMORI-HCM) · 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 NCT05850026 (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: 9 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/NCT05850026.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing