Severe Aortic Stenosis
Conditions
Keywords
aortic stenosis, TAVI, TAVR
Brief 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 degenerated mitral valves) in patients over 18 years old. 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.
Interventions
DEVICENot applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years. * Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses/rings.
Exclusion criteria
* Failure to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-years all cause death | 5 years | All-cause mortality at 5-year follow-up from the index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of in-hospital adverse events (VARC-2 criteria) | 5 years | Number of in-hospital adverse events (VARC-2 criteria) |
| Number of patients with bioprosthetic valve dysfunction | 5 years | Number of patients with bioprosthetic valve dysfunction |
| 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). | 5 years | — |
| HF Hospitalization rate | 5 years | HF Hospitalization rate |
| Acute Myocardial Infarction (AMI) | 5 years | any type of AMI (STEMI, ST-Elevation Myocardial Infarction; NSTEMI, Non-ST-Elevation Myocardial Infarction; silent AMIs) |
| Stroke/TIA | 5 years | Stroke/TIA |
| MACE | 5 years | MACE (CV death, AMI, stroke/TIA, revascularization, UA) |
Countries
Italy
Contacts
CONTACTMarco Ferlini, MD
CONTACTAlessia Currao, PM
Outcome results
None listed