Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Location status: Recruiting
NCT Number: NCT07596394
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Pavia, 27100, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
Time frame: 5 years
All-cause mortality at 5-year follow-up from the index procedure
Time frame: 5 years
Number of in-hospital adverse events (VARC-2 criteria)
Time frame: 5 years
Number of patients with bioprosthetic valve dysfunction
Time frame: 5 years
Time frame: 5 years
HF Hospitalization rate
Time frame: 5 years
any type of AMI (STEMI, ST-Elevation Myocardial Infarction; NSTEMI, Non-ST-Elevation Myocardial Infarction; silent AMIs)
Time frame: 5 years
Stroke/TIA
Time frame: 5 years
MACE (CV death, AMI, stroke/TIA, revascularization, UA)
Contact information is provided by the study sponsor or research team.
Alessia Currao, PM
CONTACT
Marco Ferlini, MD
CONTACT
Fondazione IRCCS Policlinico San Matteo di Pavia
Other
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
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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