Last reviewed · How we verify
NCT06121921
RESTORE-TAVI Pilot
NA trial testing Perioperative multi-component intervention in Frailty in 40 participants. Completed in 1 May 2025.
1 May 2025
Quick facts
| Lead sponsor | Barts & The London NHS Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 40 |
| Start date | 7 June 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Perioperative multi-component intervention
Conditions studied
- Frailty — all drugs for Frailty →
- Aortic Stenosis — all drugs for Aortic Stenosis →
Sponsor
Barts & The London NHS Trust — full company profile →
Who can join
70 and older, any sex, with Frailty or Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care. The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06121921
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Barts & The London NHS Trust trials
Trials by the same sponsor.
- NCT05753085 — Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment · NA · withdrawn
- NCT07047235 — Substrate Remodelling and Targeted Ablation in AF · NA · recruiting
- NCT06871215 — Inflammation and Infective Endocarditis · withdrawn
- NCT07076524 — MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL) · recruiting
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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 NCT06121921 (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 Barts & The London NHS Trust
- Last refreshed: 23 May 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/NCT06121921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing