Low Flow, Low Gradient Aortic StenosisLOW-TAVRNCT06589063
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis
An observational study of Low Flow, Low Gradient Aortic Stenosis, run by University of Salerno at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Flow, Low Gradient Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 1,350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 Dec 2037
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR)
Who may be able to join
- LFLG-AS diagnosis according to current European Society of Cardiology guidelines
- Age 18 years or older
- Written informed consent
Who cannot join
- LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
- LFLG-AS referred for medical treatment or undergoing surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Salerno
Salerno, 84131
Gennaro Galasso, MD, PhD, +393497441225, ggalasso@unisa.it
About this study
Official title: Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry
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.
- Conditions
- Low Flow, Low Gradient Aortic Stenosis
- Being tested
- Transcatheter aortic valve replacement
- Keywords
- aortic stenosis, transcatheter aortic valve replacement, clinical outcomes, interventional cardiology
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementDevice
Also called TAVI, TAVR, Transcatheter aortic valve implantation
Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2025
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Flow, Low Gradient Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,350 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Galasso, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589063
- Sponsor's protocol ID
- 13202409
- Acronym
- LOW-TAVR
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry
- ClinicalTrials.gov ID
- NCT06589063
- Acronym / sponsor ID
- LOW-TAVR / 13202409
- Conditions
- Low Flow, Low Gradient Aortic Stenosis
- Keywords
- aortic stenosis, transcatheter aortic valve replacement, clinical outcomes, interventional cardiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR)
Key inclusion criteria (3 listed)
- LFLG-AS diagnosis according to current European Society of Cardiology guidelines
- Age 18 years or older
- Written informed consent
Key exclusion criteria (2 listed)
- LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
- LFLG-AS referred for medical treatment or undergoing surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve replacementAlso: TAVI, TAVR, Transcatheter aortic valve implantationTranscatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses | Device | – |
Primary outcome
Composite of all-cause death and hospitalization for worsening heart failure
Time frame: 1 year
Death due to cardiac or non-cardiac cause and new hospitalization for worsening heart failure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Derived from this study: PubMed 42132173Ferruzzi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Flow, Low Gradient Aortic Stenosis, run by University of Salerno at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gennaro Galasso, MD, PhD (3497441225, ggalasso@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause death and hospitalization for worsening heart failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06589063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.