Registry of Transcatheter Aortic Valve Treatments at a Italian Center
Official 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).
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07596394 · Data updated 2026-11-12
This registry tests how safe and effective transcatheter valve procedures are in adults with severe aortic stenosis treated at a single Italian center.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | March 16, 2021 |
| Main results expected | March 21, 2030 |
| Study ends | December 2030 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07596394 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who receive transcatheter valve therapy on native aortic valves, degenerated aortic bioprostheses, or degenerated mitral prostheses/rings at the San Matteo center.
✕Probably not a fit
Patients who do not experience meaningful outcomes or who do not consent to participate may see no direct benefit from the registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The PAVI-TAVI Registry is an observational study conducted at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. It collects real-world data on transcatheter heart valve procedures, including TAVI for aortic stenosis, valve-in-valve, TAVI for aortic insufficiency, and TMVR for degenerated mitral valves. The study tracks patients aged 18 years and older who undergo these procedures on native valves or degenerated bioprostheses, with the primary outcome being all-cause mortality over five years. Secondary outcomes include procedure-related complications, valve function, inflammation markers, heart failure hospitalizations, myocardial infarction, stroke, and major adverse cardiac events. No experimental therapy is involved; the registry compiles routine clinical data from standard care. Participation hinges on informed consent.
Why it matters
Potential benefit: If successful, the registry could provide real-world evidence to improve patient selection and long-term management of transcatheter valve procedures.
How similar studies have gone: Previous observational registries in transcatheter valve therapy have shown useful insights into safety and outcomes, though each center’s data contribute unique real-world context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy Recruiting
Study contacts
- Study coordinator: Marco Ferlini, MD
- Email: m.ferlini@smatteo.pv.it
- Phone: +390382503158
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CT-FFR-guided revascularization for people with severe aortic stenosis
This study will see if adding CT-FFR (a noninvasive blood-flow test) to preoperative CT angiography helps doctors decide whether people with severe aortic stenosis need coronary revascularization before valve replacement.
-
RENATUS transcatheter aortic valve for severe aortic stenosis
This trial tests the RENATUS transcatheter aortic valve in people with symptomatic severe aortic stenosis who are eligible for TAVR.
-
Pre-emptive LAVA-ECMO support for complex, high-risk TAVR
The team will try pre-emptive left atrial veno-arterial ECMO to stabilize adults with severe aortic stenosis undergoing complex, high-risk TAVR who are unstable or at risk of instability.
-
Comparing the DurAVR transcatheter heart valve with SAPIEN and Evolut valves for severe aortic stenosis
This trial will test whether the DurAVR transcatheter heart valve works as well and is as safe as SAPIEN or Evolut valves in people with severe calcific aortic stenosis, and it also includes a registry for people needing valve‑in‑valve procedures.
-
Navitor TAVI valve in Japanese patients with severe aortic stenosis
This study will try the Navitor transcatheter aortic valve with the FlexNav delivery system in about 100 Japanese adults with symptomatic severe aortic stenosis to track safety and how well the valve works.
-
Improving quality of life for patients with severe aortic stenosis
This study looks at how severe aortic stenosis affects the daily lives of patients to see if a new heart valve procedure can help improve their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.