Status:
NOT_YET_RECRUITING
Treatment of Severe Aortic Stenosis with Transfemoral TAVI with or Without Coronary Angiogram During Diagnostic Work-up (PURE TAVI)
Lead Sponsor:
Rede Optimus Hospitalar SA
Conditions:
Severe Aortic Stenosis
Eligibility:
All Genders
18-120 years
Brief Summary
The study will be conducted in patients with Severe aortic stenosis referred to transcatheter aortic valve implantation (TAVI). The recommended treatment for severe aortic stenosis is a procedure call...
Detailed Description
This study aims to evaluate whether a TAVI pathway without prior coronary angiography is non-inferior to a conventional TAVI pathway, in which routine coronary angiography with or without revasculariz...
Eligibility Criteria
Inclusion
- Patient is older than 18 years with severe AS considered for TAVI by a multidisciplinary heart team.
- Patient is candidate for transfemoral TAVI as per local standards and current guidelines.
- Patient is willing and capable to give written consent to participate to the trial and confirmed to be able to attend the expected follow up visits.
Exclusion
- Patient had a coronary angiogram with or without PCI and/or coronary CT and/or CABG within last 5 years.
- Left main PCI in the medical history
- Patient has CCS of 3 or more.
- Patient has left ventricular ejection fraction \<30%.
- Patients in whom TAVI through femoral access is ad priori not possible based on clinical assessment or medical history
- Patient has been treated for acute myocardial infarction within 30 days before randomization.
- Patient has a planned open-heart surgery.
- Patient has a life expectancy less than 1 year due to other severe non-cardiac disease.
- Patient is participating in another clinical study with an investigational product that has not yet completed the follow up period.
- Patient has received previous treatment for aortic valve implantation or replacement.
- Female patient who is pregnant at the time of inclusion.
Key Trial Info
Start Date :
April 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
620 Patients enrolled
Trial Details
Trial ID
NCT06898086
Start Date
April 30 2025
End Date
October 30 2028
Last Update
March 27 2025
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