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NCT04639258
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
NA trial testing Medtronic Evolut™ PRO+ System in Aortic Valve Stenosis in 11 participants. Terminated before completion.
7 June 2022
Quick facts
| Lead sponsor | Medtronic Cardiovascular |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 28 May 2021 |
| Primary completion | 7 June 2022 |
| Estimated completion | 7 June 2022 |
| Sites | 8 locations across New Zealand, Israel, Canada, Australia, United States |
Drugs / interventions tested
- Medtronic Evolut™ PRO+ System
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
Sponsor
Medtronic Cardiovascular — full company profile →
Who can join
65 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected from study enrollment (consent) through study exit, up to 151 days. First subject was enrolled on 28 May 2021 and last subject was exited on 28 Feb 2022. No study subjects were treated. If subjects had been treated all AEs would have been reported through 6 months post-procedure. After 6 months post-procedures only serious adverse events, device-related events, and device deficiencies would have been reported.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (3 terms)
| Reaction | System | TAVR |
|---|---|---|
| Coronary stenosis | Cardiac disorders | — |
| Left radial artery pseudoaneurysm following study specific angiogram | Injury, poisoning and procedural complications | — |
| Haematome, left radial | Vascular disorders | — |
Other adverse events (4 terms — click to expand)
| Reaction | System | TAVR |
|---|---|---|
| Scalp laceration | Injury, poisoning and procedural complications | — |
| Parasthesia, left thumb and index finger | Nervous system disorders | — |
| Bilateral ovarian cysts | Reproductive system and breast disorders | — |
| Saccular infrarenal abdominal aortic aneurysm | Vascular disorders | — |
Most-reported serious reactions: Coronary stenosis, Left radial artery pseudoaneurysm following study specific angiogram, Haematome, left radial.
Data from ClinicalTrials.gov NCT04639258 adverse events section.
Sponsor's own description
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evolving Indications of Transcatheter Aortic Valve Replacement-Where Are We Now, and Where Are We Going.
Mesnier J, Panagides V, Nuche J, Rodés-Cabau J. · · 2022 · cited 26× · PMID 35683476 · DOI 10.3390/jcm11113090
Verify or expand the search:
- PubMed search for NCT04639258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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
- NCT04433065 — TTVR Early Feasibility Study · NA · recruiting
- NCT04267055 — DISSECT-N Post Market Data Collection Registry · completed
- NCT04091048 — Optimize PRO Study · 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 NCT04639258 (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: 10 January 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/NCT04639258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing