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).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo.
- Who it may be relevant to
- Registry conditions: Severe Aortic Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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).
Overview
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
- Device 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
Primary outcome measures
- 5-years all cause death [Time frame: 5 years]
Secondary outcome measures (7)
- Number of in-hospital adverse events (VARC-2 criteria) [Time frame: 5 years]
- Number of patients with bioprosthetic valve dysfunction [Time frame: 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). [Time frame: 5 years]
- HF Hospitalization rate [Time frame: 5 years]
- Acute Myocardial Infarction (AMI) [Time frame: 5 years]
- Stroke/TIA [Time frame: 5 years]
- MACE [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo — Pavia
Identifiers
NCT: NCT07596394 · PAVI_TAVI Registry