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NCT06603454: GUIDE-SAVR
Preoperative Chest CT-imaging in Surgical Aortic Valve Replacement with or Without CABG
NA trial testing Preoperative CT in Aortic Valve Stenosis in 380 participants. Currently enrolling.
1 April 2025
Quick facts
| Lead sponsor | Romy Hegeman |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 380 |
| Start date | 4 December 2023 |
| Primary completion | 1 April 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Preoperative CT
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
Sponsor
Romy Hegeman
Who can join
18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Rationale When determining the strategy for aortic valve replacement, echocardiography is still considered the golden standard (1). While pre-procedural MSCT is standard of care in TAVR patients, this is not yet part of routine clinical practice in SAVR patients. The researchers hypothesise that when atherosclerosis of the ascending aorta is identified preoperatively on contrast-enhanced multi-slice computed tomography (MSCT), the subclinical perioperative stroke rate (as detected on diffusion-weighted magnetic resonance imaging (DW-MRI)) can be reduced by modification of the operative strategy if necessary.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06603454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Romy Hegeman trials
Trials by the same sponsor.
- NCT05788770 — Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement · NA · recruiting
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 NCT06603454 (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 Romy Hegeman
- Last refreshed: 19 September 2024
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/NCT06603454.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing