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NCT04350658: TAVIWOP
TAVR Without Predilatation
trial testing Transcatheter aortic valve implantation required for symptomatic aortic stenosis in Aortic Stenosis in 138 participants. Status unknown.
1 July 2021
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 138 |
| Start date | 1 June 2020 |
| Primary completion | 1 July 2021 |
| Estimated completion | 1 April 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Transcatheter aortic valve implantation required for symptomatic aortic stenosis
Conditions studied
- Aortic Stenosis — all drugs for Aortic Stenosis →
Sponsor
University Hospital, Montpellier
Who can join
18 and older, any sex, with Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04350658
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04350658 (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 University Hospital, Montpellier
- Last refreshed: 11 November 2021
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/NCT04350658.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing