Last updated: April 5, 2024
Sponsor: Azienda Usl di Bologna
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
TAVI WITH ON-SITE SURGERY
TAVI WITHOUT ON-SITE SURGERY
Clinical Study ID
NCT05751577
40-2023-SPER-AUSLBO
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Severe aortic stenosis
- Indication to TAVI confirmed by the Study Heart Team AND one of the following:
- Inoperable due to prohibitive operative risk
- High surgical risk as defined as STS score >8% The presence of at least one clinical factor that, by unanimous judgment of the Study HeartTeam, compromises the benefit/risk ratio in the case of emergent cardiac surgery:
- Porcelain aorta or severely atherosclerotic aorta
- Frailty/Reduced physical performance
- Cognitive impairment, dementia, or Parkinson's disease
- Severe liver disease/cirrhosis
- Hostile chest
- Internal mammalian artery or other critical conduit(s) crossing midline and/oradhering to the posterior table of the sternum
- Severe pulmonary hypertension and/or severe right ventricular dysfunction
- Severe Chronic Obstructive Pulmonary Disease (COPD)
- Age ≥85 years
Exclusion
Exclusion Criteria:
- Unsuitable for transfemoral TAVI
- Emergent TAVI
- Noncardiovascular comorbidity reducing life expectancy to <1 year
- Any factor precluding 1-year follow-up
- Refusal informed consent
Study Design
Total Participants: 566
Treatment Group(s): 2
Primary Treatment: TAVI WITH ON-SITE SURGERY
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 01, 2028
Study Description
Connect with a study center
Ospedale San Donato di Arezzo
Arezzo,
ItalyActive - Recruiting
Ospedale Cardinal Massaia di Asti
Asti,
ItalyActive - Recruiting
Ospedale degli Infermi di Biella
Biella,
ItalyActive - Recruiting
Azienda Unità Sanitaria Locale
Bologna, 40100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria di Ferrara
Ferrara,
ItalyActive - Recruiting
Ospedale Misericordia di Grosseto
Grosseto,
ItalyActive - Recruiting
Azienda ULSS 3 Serenissima, Ospedale di Mirano
Mirano,
ItalyActive - Recruiting
Ospedale Guglielmo da Saliceto di Piacenza
Piacenza,
ItalyActive - Recruiting
Azienda Ospedaliera di Reggio Emilia
Reggio Emilia,
ItalyActive - Recruiting
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