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LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) and, in particular:
LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR).
The register aims to include at least 1350 patients diagnosed with LFLG-AS undergoing TAVR at the participating centres.
The inclusion criteria are:
The exclusion criteria are:
Clinical outcome is evaluated at a 30-day, 1-year, 2-year, and 5-year follow-up.
The primary endpoint of interest of the registry is the assessment of the incidence of the composite of all-cause mortality and hospitalization for heart failure at one year.
The secondary endpoints are the assessment of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve replacement | Device | Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause death and hospitalization for worsening heart failure | Death due to cardiac or non-cardiac cause and new hospitalization for worsening heart failure | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gennaro Galasso, MD, PhD | Contact | 3497441225 | ggalasso@unisa.it | |
| Angelo Silverio, MD, PhD | Contact | 3286924815 | asilverio@unisa.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Salerno | Recruiting | Salerno | 84131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42132173 | Derived | Ferruzzi GJ, Bellino M, Silverio A, Saia F, Bruno AG, Boragine P, Buono A, De Rosa ML, Cancro FP, Porto I, Crimi G, Calabro P, Moscarella E, Ielasi A, Montonati C, De Carlo M, Sticchi A, Lanni F, Di Muro FM, Maiellaro F, Calchera IF, Boccuzzi G, Sorropago A, Scudiero F, Attisano T, Citro R, Granata G, De Luca G, Musumeci G, Galasso G; LOW-TAVR Investigators. Balloon-Expandable Versus Self-Expanding Prostheses for Transcatheter Treatment of Patients With Low-Flow, Low-Gradient Aortic Stenosis. J Am Heart Assoc. 2026 May 19;15(10):e046441. doi: 10.1161/JAHA.125.046441. Epub 2026 May 14. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: First study protocol and statistical analysis plan | Feb 12, 2024 | Sep 13, 2024 | Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Updated study protocol and statistical analysis plan | May 14, 2024 | Apr 1, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2024 | Sep 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |