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RecruitingNCT06589063LOW-TAVRUpdated Apr 7, 2026

Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis

An observational study in Low Flow, Low Gradient Aortic Stenosis, sponsored by University of Salerno. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by University of Salerno · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,350
Ages
18 Years and older
Sex
All
01

Study summary

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:

  • risk factors
  • gender differences
  • comorbidities
  • pharmacological treatment
  • TAVR procedural characteristics
  • periprocedural and in-hospital complications
  • clinical outcome at 30-day, 1-year, 2-year and 5-year follow-up
Read the detailed description

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:

  • LFLG-AS diagnosis according to current European Society of Cardiology guidelines
  • Age 18 years or older
  • Written informed consent

The exclusion criteria are:

  • LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
  • LFLG-AS referred for medical treatment or undergoing surgery

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:

  • periprocedural TAVR complications: complete atrioventricular block, stroke, acute myocardial infarction, acute aortic insufficiency, cardiogenic shock, acute pulmonary edema, cardiac tamponade, aortic rupture;
  • adverse events during hospitalization: major and minor bleeding, major and minor vascular complications, definitive pacemaker implantation, cardiogenic shock, myocardial infarction, stroke, and death;
  • adverse events at 30 days, one year, two years, and five years: all-cause mortality, hospitalizations for heart failure, cardiovascular mortality, myocardial infarction, stroke, major and minor bleedings.
02

Conditions studied

  • Low Flow, Low Gradient Aortic Stenosis

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Keywords

  • aortic stenosis
  • transcatheter aortic valve replacement
  • clinical outcomes
  • interventional cardiology
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 1,350 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

University of Salerno is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR)

Inclusion criteria

  • LFLG-AS diagnosis according to current European Society of Cardiology guidelines
  • Age 18 years or older
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
  • LFLG-AS referred for medical treatment or undergoing surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,350 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • DeviceTranscatheter aortic valve replacement

    Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses

    Also known as: TAVI, TAVR, Transcatheter aortic valve implantation

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • University of Salerno
    Salerno, 84131, Italy
    Recruiting
08

References and documents

Publications

  • 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. PubMed 42132173 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 12, 2024
  • Protocol and statistical analysis plan · May 14, 2024
  • Informed consent form · Feb 12, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06589063
Lead sponsor
University of Salerno
Responsible party
Gennaro Galasso (Professor, University of Salerno) — Principal investigator
First posted
Sep 19, 2024
Start date
Mar 1, 2024
Primary completion
Sep 1, 2025
Completion
Dec 31, 2037 (estimated)
Last update
Apr 7, 2026

Study contacts

Gennaro Galasso, MD, PhD
Contact
ggalasso@unisa.it
3497441225
Angelo Silverio, MD, PhD
Contact
asilverio@unisa.it
3286924815

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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