Evaluating outcomes of transcatheter aortic valve replacement for severe low flow, low gradient aortic stenosis
Official title: Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry
Run by University of Salerno · NCT06589063 · Data updated 2026-11-12
This study is testing how well transcatheter aortic valve replacement works for people with severe low flow, low gradient aortic stenosis and tracking their health outcomes over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1350 (estimated) |
| Sponsor | University of Salerno Academic / other |
| Locations | 1 site (Salerno) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | September 1, 2025 |
| Study ends | December 31, 2037 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT06589063 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 years or older diagnosed with severe low flow, low gradient aortic stenosis according to European Society of Cardiology guidelines.
✕Probably not a fit
Patients with pseudo-severe or non-confirmed severe aortic stenosis, or those referred for medical treatment instead of TAVR, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The LOW-TAVR registry is a multicenter initiative in Italy that aims to assess the clinical characteristics and outcomes of patients with severe low flow, low gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR). This observational study will include at least 1,500 patients and evaluate various factors such as risk factors, gender differences, comorbidities, and procedural characteristics. Clinical outcomes will be monitored at multiple follow-up points, including 30 days, 1 year, 2 years, and 5 years, focusing on all-cause mortality and hospitalization for heart failure. The study will also assess the incidence of complications associated with the TAVR procedure.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of TAVR for patients with severe low flow, low gradient aortic stenosis.
How similar studies have gone: Other studies have shown success with TAVR in various patient populations, but this specific focus on low flow, low gradient aortic stenosis is less commonly explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * LFLG-AS diagnosis according to current European Society of Cardiology guidelines * Age 18 years or older * Written informed consent Exclusion Criteria: * LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis * LFLG-AS referred for medical treatment or undergoing surgery
Where it's running
-
University of Salerno
Salerno, Italy Recruiting
Study contacts
- Study coordinator: Gennaro Galasso, MD, PhD
- Email: ggalasso@unisa.it
- Phone: 3497441225
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.