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NCT04663334
Change in Coronary Microcirculation and FFR After TAVI in Patients With Cardiovascular Comorbidities
trial testing inverse myocardial remodeling in Severe Symptomatic Aortic Stenosis in 29 participants. Completed in 8 May 2023.
8 May 2023
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 29 |
| Start date | 8 December 2020 |
| Primary completion | 8 May 2023 |
| Estimated completion | 8 May 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- inverse myocardial remodeling
Conditions studied
- Severe Symptomatic Aortic Stenosis — all drugs for Severe Symptomatic Aortic Stenosis →
Sponsor
Nantes University Hospital
Who can join
18 and older, any sex, with Severe Symptomatic Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis. Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its prognostic impact is not clearly established, and available studies uncommonly used functional assessment of severity from a coronary stenosis to stratify the risk in this situation. Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous coronary intervention (PCI) in clinical practice. Its use is not validated in patients with severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After aortic valvular replacement, a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment. The aim of the study is to assess the effects of inverse myocardial remodeling on coronary microcirculatory function and its association with FFR values before and after TAVI.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Changes in microcirculation following transcatheter aortic valve implantation in patients with stable coronary artery disease.
Battistolo Q, Le Ruz R, Piriou PG, Guerin P, et al · · 2025 · PMID 39827054 · DOI 10.1016/j.acvd.2024.12.006
Verify or expand the search:
- PubMed search for NCT04663334
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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 NCT04663334 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 15 December 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/NCT04663334.
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