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NCT05264181: EUROPULMS3
Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve
trial testing Percutaneous pulmonary valve implantation in Pulmonary Valve; Failure in 600 participants. Status unknown.
1 March 2022
Quick facts
| Lead sponsor | Centre Chirurgical Marie Lannelongue |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 1 September 2021 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 August 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Percutaneous pulmonary valve implantation
Conditions studied
- Pulmonary Valve; Failure — all drugs for Pulmonary Valve; Failure →
- Percutaneous Pulmonary Valve Implantation — all drugs for Percutaneous Pulmonary Valve Implantation →
- Infective Endocarditis — all drugs for Infective Endocarditis →
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
Sponsor
Centre Chirurgical Marie Lannelongue — full company profile →
Who can join
Adults 5 to 110, any sex, with Pulmonary Valve; Failure or Percutaneous Pulmonary Valve Implantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right ventricular outflow tract dysfunction in patients with congenital heart diseases. Long-term outcomes following this procedure using the new generation SAPIEN 3 valve is little known. Purpose This study aims to report mid-term outcomes in a large cohort of patients who had TPVI using the SAPIEN 3 valve. Methods We designed a retrospective multicentre observational registry of patients undergoing TPVI with the SAPIEN 3 valve across centres in Europe, Middle-east and Canada. Patient-related, procedural, and mid-term outcomes data will be characterized.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05264181
- 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 NCT05264181 (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 Centre Chirurgical Marie Lannelongue
- Last refreshed: 3 March 2022
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/NCT05264181.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing