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).

NCT07596394 | Recruiting

• 1 other identifier: PAVI_TAVI Registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Aortic Stenosis

Keywords

aortic stenosis; TAVI; TAVR

Outcome Measures

Primary Outcomes (1)

• 5-years all cause death

  All-cause mortality at 5-year follow-up from the index procedure

  5 years

Secondary Outcomes (7)

• Number of in-hospital adverse events (VARC-2 criteria)

  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).

  5 years

• HF Hospitalization rate

  5 years

• Acute Myocardial Infarction (AMI)

  5 years

Study Arms (1)

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

Interventions

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 Sa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years.
• Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses/rings.

You may not qualify if:

• Failure to sign the informed consent.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Marco Ferlini, MD

CONTACT

+390382503158; m.ferlini@smatteo.pv.it

Alessia Currao, PM

CONTACT

+39 0382503739; a.currao@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 19, 2026
• Study Start: March 16, 2021
• Primary Completion (Estimated): March 21, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

IT (1)