Evaluating outcomes of transcatheter aortic valve replacement for severe low flow, low gradient aortic stenosis
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry
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 |
|---|---|
| Enrollment | 1350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Salerno Academic / other |
| Locations | 1 site (Salerno) |
| Trial ID | NCT06589063 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Salerno
- University of Salerno — Salerno, Italy (Recruiting)
Study contacts
- Study coordinator: Gennaro Galasso, MD, PhD
- Email: ggalasso@unisa.it
- Phone: 3497441225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.