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NCT Number: NCT07596394

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 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Marco Ferlini, MD

CONTACT

[email protected]

+39 0382503158

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 5-years all cause death

    Time frame: 5 years

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

Secondary outcomes

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

    Time frame: 5 years

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

  2. Number of patients with bioprosthetic valve dysfunction

    Time frame: 5 years

    Number of patients with bioprosthetic valve dysfunction

  3. 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

  4. HF Hospitalization rate

    Time frame: 5 years

    HF Hospitalization rate

  5. Acute Myocardial Infarction (AMI)

    Time frame: 5 years

    any type of AMI (STEMI, ST-Elevation Myocardial Infarction; NSTEMI, Non-ST-Elevation Myocardial Infarction; silent AMIs)

  6. Stroke/TIA

    Time frame: 5 years

    Stroke/TIA

  7. MACE

    Time frame: 5 years

    MACE (CV death, AMI, stroke/TIA, revascularization, UA)

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia Currao, PM

CONTACT

[email protected]

+39 0382503739

Marco Ferlini, MD

CONTACT

[email protected]

+390382503158

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study 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).

Acronym: PAVI_TAVI

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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