Last reviewed · How we verify
NCT05501652
ALLEVIATE-HF-HD Study
Phase 1 trial testing ALV1System in Heart Failure in 5 participants. Completed in 3 February 2023.
22 August 2022
Quick facts
| Lead sponsor | Alleviant Medical, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 30 June 2022 |
| Primary completion | 22 August 2022 |
| Estimated completion | 3 February 2023 |
| Sites | 1 location across Georgia |
Drugs / interventions tested
- ALV1System
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
Alleviant Medical, Inc.
Who can join
40 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF 25-39%), or mid-range left ventricular ejection fraction (HFmrEF, EF 40-49%), or preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%), with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Atrial Mechanics in Heart Failure With Preserved Ejection Fraction: Effect of a No-Implant Interatrial Shunt.
Laufer-Perl M, Flint N, Arbel Y, Alenezi F, et al · · 2025 · cited 1× · PMID 40899260 · DOI 10.1161/circheartfailure.124.012573 -
Phenotype characterization of heart failure with preserved ejection fraction in medical device and surgical trials.
Araz K, Fioretti F, Ladak S, Obaidan M, et al · · 2025 · cited 1× · PMID 40857067 · DOI 10.1002/ehf2.15401
Verify or expand the search:
- PubMed search for NCT05501652
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other Alleviant Medical, Inc. trials
Trials by the same sponsor.
- NCT05685303 — Alleviant ALLAY-HF Study · NA · enrolling by invitation
- NCT05133089 — ALLEVIATE-HFrEF Study · Phase 1 · completed
- NCT04838353 — Alleviate-HF-2 Study · NA · completed
- NCT04583527 — Alleviate-HF-1 Study · Phase 1 · 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 NCT05501652 (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 Alleviant Medical, Inc.
- Last refreshed: 18 July 2023
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/NCT05501652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing