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NCT03595423: SPAVALVE
SPAnish Aortic VALVE Multicentric Study
trial testing Surgical AVR with bioprosthetic or mechanical prosthesis in Survival, Prosthesis in 5,000 participants. Status unknown.
31 March 2019
Quick facts
| Lead sponsor | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 5,000 |
| Start date | 10 July 2018 |
| Primary completion | 31 March 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Surgical AVR with bioprosthetic or mechanical prosthesis
Conditions studied
- Survival, Prosthesis — all drugs for Survival, Prosthesis →
- Prosthesis Durability — all drugs for Prosthesis Durability →
- Valve Heart Disease — all drugs for Valve Heart Disease →
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud — full company profile →
Who can join
Adults 50 to 65, any sex, with Survival, Prosthesis or Prosthesis Durability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Currently there is an increase in the use of bioprosthesis worldwide (\> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B. Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era. The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 30 Cardiovascular Surgery Centers in Spain
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03595423
- 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 NCT03595423 (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 Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Last refreshed: 23 July 2018
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/NCT03595423.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing