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NCT03417011
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System
trial testing Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System) in Aortic Valve Stenosis in 638 participants. Completed in 26 February 2024.
6 March 2019
Quick facts
| Lead sponsor | Medtronic Cardiovascular |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 638 |
| Start date | 26 February 2018 |
| Primary completion | 6 March 2019 |
| Estimated completion | 26 February 2024 |
| Sites | 39 locations across France, Denmark, Finland, Italy, Netherlands, Belgium, Austria, United Kingdom |
Drugs / interventions tested
- Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
Sponsor
Medtronic Cardiovascular — full company profile →
Who can join
Eligibility, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system. The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study.
Manoharan G, Grube E, Van Mieghem NM, Brecker S, et al · · 2020 · cited 27× · PMID 32748789 · DOI 10.4244/eij-d-20-00279 -
Three-Year Outcomes With a Supra-Annular, Self-Expanding Bioprosthesis and a Pericardial Wrap-The FORWARD PRO Study.
Van Mieghem NM, Windecker S, Manoharan G, Lancellotti P, et al · · 2025 · PMID 39686582 · DOI 10.1002/ccd.31335
Verify or expand the search:
- PubMed search for NCT03417011
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aortic Valve Stenosis
Currently open trials in the same condition.
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- NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
- NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting
Other Medtronic Cardiovascular trials
Trials by the same sponsor.
- NCT06906926 — Harmony TPV EMEA PMS · NA · recruiting
- NCT04982588 — Evolut PRO China Clinical Study · NA · active not recruiting
- NCT04639258 — Medtronic Evolut™ EXPAND TAVR I Feasibility Study · NA · terminated
- NCT04433065 — TTVR Early Feasibility Study · NA · recruiting
- NCT04267055 — DISSECT-N Post Market Data Collection Registry · 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 NCT03417011 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Medtronic Cardiovascular
- Last refreshed: 9 September 2025
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/NCT03417011.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing