Aortic Valve Stenosis Clinical Trials

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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).

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years.

• Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses/rings.

Locations
Other Locations
Italy
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Contact Information
Primary
Marco Ferlini, MD
m.ferlini@smatteo.pv.it
+390382503158
Backup
Alessia Currao, PM
a.currao@smatteo.pv.it
+39 0382503739
Time Frame
Start Date: 2021-03-16
Estimated Completion Date: 2030-12
Participants
Target number of participants: 500
Treatments
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
Sponsors
Leads: Fondazione IRCCS Policlinico San Matteo di Pavia

This content was sourced from clinicaltrials.gov