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NCT03680040: RESILIENCE
RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65
trial testing Subjects previously implanted with a RESILIA aortic tissue valve. in Aortic Valve Replacement in 110 participants. Terminated before completion.
13 February 2024
Quick facts
| Lead sponsor | Edwards Lifesciences |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 110 |
| Start date | 5 November 2018 |
| Primary completion | 13 February 2024 |
| Estimated completion | 13 February 2024 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Subjects previously implanted with a RESILIA aortic tissue valve.
Conditions studied
- Aortic Valve Replacement — all drugs for Aortic Valve Replacement →
Sponsor
Edwards Lifesciences — full company profile →
Who can join
Adults 18 to 64, any sex, with Aortic Valve Replacement. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry.
Meuris B, Borger MA, Bourguignon T, Siepe M, et al · · 2020 · cited 16× · PMID 32460798 · DOI 10.1186/s13019-020-01155-6 -
Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.
Bakhtiary F, Ahmad AE, Autschbach R, Benedikt P, et al · · 2021 · cited 5× · PMID 33766089 · DOI 10.1186/s13019-021-01434-w
Verify or expand the search:
- PubMed search for NCT03680040
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Valve Replacement
Currently open trials in the same condition.
- NCT07123480 — The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance · NA · active not recruiting
- NCT05295628 — Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR · NA · active not recruiting
Other Edwards Lifesciences trials
Trials by the same sponsor.
- NCT07317648 — ClearSight NextGen1 Study · NA · completed
- NCT06833476 — TTVR STRONG Under Coverage With Evidence Development (CED) Study · recruiting
- NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting
- NCT06834516 — ClearSight Baby Cuff · completed
- NCT05957406 — SMART TRENDS Study · NA · completed
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 NCT03680040 (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 Edwards Lifesciences
- Last refreshed: 9 May 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/NCT03680040.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing