Severe Aortic StenosisPAVI_TAVINCT07596394
A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy).
An observational study of Severe Aortic Stenosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
PAVI-TAVI Registry Overview The PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. It tracks real-world outcomes of transcatheter heart valve procedures like TAVI (for aortic stenosis), valve-in-valve (VIV), TAVI for aortic insufficiency (TAVI-IAo), and TMVR (for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- What is being tested?
- Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 16 Mar 2021to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
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: All patients treated with TAVI, VIV, TAVI-IAo, and TMVR at Fondazione IRCCS Policlinico San Matteo will be eligible for enrollment.
Who may be able to join
- Age > 18 years.
- Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses/rings.
Who cannot join
- Failure to sign the informed consent.
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
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Marco Ferlini, MD, +39 0382503158, m.ferlini@smatteo.pv.it
About this study
Official title: A Prospective and Retrospective Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (PAVI_TAVI Registry).
PAVI-TAVI Registry Overview
The PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. It tracks real-world outcomes of transcatheter heart valve procedures like TAVI (for aortic stenosis), valve-in-valve (VIV), TAVI for aortic insufficiency (TAVI-IAo), and TMVR (for degenerated mitral valves) in patients over 18 years old.
Read more
Who Can Join Eligible patients include adults treated with these procedures on native aortic valves, failed aortic bioprostheses, or degenerated mitral prostheses/rings. The only exclusion is not providing informed consent.
Study Goals The main goal is to evaluate TAVI's safety and effectiveness over 5 years, focusing on all-cause mortality from the initial procedure. Secondary goals assess complication rates, valve function, inflammation markers, heart failure hospitalizations, heart attacks, strokes, and major cardiac events.
How It Works No experimental treatments-it's a registry collecting routine clinical data via a secure electronic system. Follow-up happens at your doctor's discretion, ideally at 3 and 12 months, then yearly (often by phone for stable cases). The study aims to enroll 500+ patients.
- Conditions
- Severe Aortic Stenosis
- Being tested
- Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
- Keywords
- aortic stenosis, TAVI, TAVR
- 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.
Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San MatteoDevice
Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
| Study group | Role | What they receive |
|---|---|---|
| Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico Sa | Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo Receives: Device: Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-years all cause death
All-cause mortality at 5-year follow-up from the index procedure
Measured: 5 years
Secondary outcomes (7)
Number of in-hospital adverse events (VARC-2 criteria)
Number of in-hospital adverse events (VARC-2 criteria)
Measured: 5 years
Number of patients with bioprosthetic valve dysfunction
Number of patients with bioprosthetic valve dysfunction
Measured: 5 years
Assessment of pre- and post-procedural inflammatory indices (neutrophil-to-lymphocyte ratio and uric acid), if available, in TAVI-treated patients and correlation with clinical outcomes and prosthesis degeneration (SVD).
Measured: 5 years
HF Hospitalization rate
HF Hospitalization rate
Measured: 5 years
Acute Myocardial Infarction (AMI)
any type of AMI (STEMI, ST-Elevation Myocardial Infarction; NSTEMI, Non-ST-Elevation Myocardial Infarction; silent AMIs)
Measured: 5 years
Stroke/TIA
Stroke/TIA
Measured: 5 years
MACE
MACE (CV death, AMI, stroke/TIA, revascularization, UA)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start16 Mar 2021
- Primary completion21 Mar 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ferlini, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596394
- Sponsor's protocol ID
- PAVI_TAVI Registry
- Acronym
- PAVI_TAVI
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided