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.

Study Overview

• Status: Recruiting
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Device: Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Marco Ferlini, MD; Phone Number: +390382503158; Email: m.ferlini@smatteo.pv.it
• Study Contact Backup: Name: Alessia Currao, PM; Phone Number: +39 0382503739; Email: a.currao@smatteo.pv.it

Study Locations

• Italy
  • Pavia
    • Pavia, Pavia, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San matteo
      • Contact: Marco Ferlini, MD; Phone Number: +39 0382503158; Email: m.ferlini@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients treated with TAVI, VIV, TAVI-IAo, and TMVR at Fondazione IRCCS Policlinico San Matteo will be eligible for enrollment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-years all cause death	All-cause mortality at 5-year follow-up from the index procedure	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of in-hospital adverse events (VARC-2 criteria)	Number of in-hospital adverse events (VARC-2 criteria)	5 years
Number of patients with bioprosthetic valve dysfunction	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).		5 years
HF Hospitalization rate	HF Hospitalization rate	5 years
Acute Myocardial Infarction (AMI)	any type of AMI (STEMI, ST-Elevation Myocardial Infarction; NSTEMI, Non-ST-Elevation Myocardial Infarction; silent AMIs)	5 years
Stroke/TIA	Stroke/TIA	5 years
MACE	MACE (CV death, AMI, stroke/TIA, revascularization, UA)	5 years

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): March 21, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: aortic stenosis; TAVI; TAVR
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: PAVI_TAVI Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No