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NCT06797687: MAS-3D
Mitral Valve Annulus Assessment, Multimodality Imaging
trial testing Cardiac computed tomography in Mitral Regurgitation in 80 participants. Currently enrolling.
15 March 2026
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 15 March 2025 |
| Primary completion | 15 March 2026 |
| Estimated completion | 15 May 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Cardiac computed tomography
Conditions studied
- Mitral Regurgitation — all drugs for Mitral Regurgitation →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The success of mitral valve repair with annuloplasty depends on the repair technique and on the choice of a ring with appropriate dimensions related to mitral annulus. Intraoperatively, the choice of the prosthetic ring size is made by the surgeon using special gauges that are placed on the anterior mitral leaflet (having the trigons and commissures as anatomical findings), a method considered the gold standard for defining annulus size. However, it is performed in cardioplegia, without considering annulus shape and motion during cardiac cycle. Three-dimensional techniques are fundamental in evaluating mitral valve structure and its changes during cardiac cycle; three-dimensional transoesophageal echocardiography (3D-TOE) has been proven to be essential for the anatomo-functional characterization of mitral valve apparatus in patients undergoing surgically mitral valve repair. It also allows the measurement of quantitative parameters useful in determining the size of the annuloplasty ring, such as A2 scallop height, intertrigonal distance, intercommissural diameter and total annular perimeter size, that will support the surgeon's choice on the dimensions of the ring to be implanted. Cardiac computed tomography (CCT) plays a key role for device sizing in patients undergoing transcatheter mitral valve replacement; it provides isotropic sub-millimetre spatial resolution and it is the gold standard for geometric characterisation of the mitral valve and for assessment of the spatial relationship of mitral valve apparatus to adjacent anatomical structures. In patients undergoing mitral valve surgery it is foremost performed to exclude coronary artery disease, as stated by European Society of Cardiology (ESC) guidelines. Several studies have compared CCT with 3D-TOE in sizing the mitral valve apparatus: Shanks et al. have demonstrated a good correlation between the two techniques in measuring intercommissural diameter; Hirasawa et al. have demonstrated a good correlation in evaluating intertrigonal distance. Only one study has compared the measures of the annulus obtained by CCT with the prosthetic ring (Alkhadi et al.) and only for 9 patients the intercommissural diameter was compared to the prosthetic ring, obtaining a good correlation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06797687
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Mitral Regurgitation
Currently open trials in the same condition.
- NCT07450911 — A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System · Phase 1 · recruiting
- NCT07366723 — The Role of cardIac magNeTic rEsonance in surGical Decision Making in Patients With Severe pRimAry miTral rEgurgitation · NA · active not recruiting
- NCT07007143 — STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication fo · Phase 4 · recruiting
- NCT07108907 — Outcome Registry and Assessment of New Edge-to-Edge Repair · recruiting
- NCT06901466 — STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for O · Phase 4 · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
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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 NCT06797687 (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 Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 15 August 2025
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/NCT06797687.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing