Status:
ACTIVE_NOT_RECRUITING
Functional Assessment in TAVI: FAITAVI
Lead Sponsor:
Universita di Verona
Conditions:
Coronary Artery Disease
Aortic Valve Stenosis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardia...
Detailed Description
Nowadays there are no clear recommendations about treatment of coronary in patients with severe aortic valve stenosis eligible for percutaneous valve replacement, and those available rely on a "common...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Written informed consent
- Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team
- Diagnosis of at least one coronary stenosis \>50% at angiography
- No specific pharmacologic treatment is required to enter the study
Exclusion
- Age \< 18 years
- Pregnancy
- Lack of informed consent
- Impaired left ventricular function
- Signs or symptoms of acute (unstable) myocardial ischemia
- Contraindication to adenosine administration (e.g., asthma, chronic obstructive pulmonary disease, heart rate \<50 beats/min, and systolic blood pressure \<90 mmHg)
- Reduced survival expectancy due to severe co-morbidities (\<1 year)
- Impossibility to obtain follow-up information
- The lack of any of inclusion criteria
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03360591
Start Date
November 24 2017
End Date
June 1 2025
Last Update
March 21 2025
Active Locations (1)
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1
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126