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). (PAVI_TAVI)
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.
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Marco Ferlini, MD
- Telefonnummer: +390382503158
- E-post: m.ferlini@smatteo.pv.it
Studer Kontakt Backup
- Navn: Alessia Currao, PM
- Telefonnummer: +39 0382503739
- E-post: a.currao@smatteo.pv.it
Studiesteder
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Pavia
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Pavia, Pavia, Italia, 27100
- Rekruttering
- Fondazione IRCCS Policlinico San Matteo
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Ta kontakt med:
- Marco Ferlini, MD
- Telefonnummer: +39 0382503158
- E-post: m.ferlini@smatteo.pv.it
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
|
Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
5-years all cause death
Tidsramme: 5 years
|
All-cause mortality at 5-year follow-up from the index procedure
|
5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of in-hospital adverse events (VARC-2 criteria)
Tidsramme: 5 years
|
Number of in-hospital adverse events (VARC-2 criteria)
|
5 years
|
|
Number of patients with bioprosthetic valve dysfunction
Tidsramme: 5 years
|
Number of patients with bioprosthetic valve dysfunction
|
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).
Tidsramme: 5 years
|
5 years
|
|
|
HF Hospitalization rate
Tidsramme: 5 years
|
HF Hospitalization rate
|
5 years
|
|
Acute Myocardial Infarction (AMI)
Tidsramme: 5 years
|
any type of AMI (STEMI, ST-Elevation Myocardial Infarction; NSTEMI, Non-ST-Elevation Myocardial Infarction; silent AMIs)
|
5 years
|
|
Stroke/TIA
Tidsramme: 5 years
|
Stroke/TIA
|
5 years
|
|
MACE
Tidsramme: 5 years
|
MACE (CV death, AMI, stroke/TIA, revascularization, UA)
|
5 years
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PAVI_TAVI Registry
Plan for individuelle deltakerdata (IPD)
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