Status:
UNKNOWN
Study of New Predictors and Short Term Outcomes of Paravalvular Leakage After Transcatheter Aortic Valve Implanation
Lead Sponsor:
Marwan Sayed Mahmoud
Conditions:
Paravalvular Leakage After TAVI
Eligibility:
All Genders
Brief Summary
The presence of aortic regurgitation (AR) jet from the aorta into the left ventricle is the most common complication after TAVI, occurring in about 70% of patients but usually trivial or mild (4, 5). ...
Detailed Description
Aim of work Assessment of new predictors and short term outcomes of paravalvular leakage after transcatheter aortic valve implantation (TAVI). These new predictors are : * Eccentricity of aortic val...
Eligibility Criteria
Inclusion
- The following will be eligible for TAVI :
- Intermediate or high risk patient for surgical aortic valve replacement (SAVR) STS/EuroSCORE II \>4% or logistic EuroSCORE I \>10%(10).
- Contraindications for open chest surgery, such as(10) :
- Expected high perioperative risk due to comorbidities not adequately reflected by scores :
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- Procelain aorta
- Squelae of chest radiation.
- Severe chest deformation or scoliosis.
- Previous cardiac surgery .
Exclusion
- A-clinical conditions.
- active endocarditis,
- myocardial infarction within 14 days
- cardiogenic shock
- Life expectancy of less than 1 year
- B-Anatomical conditions:
- short distance between coronary ostia and aortic valve annulus.
- Size of aortic annulus out of range for TAVI(range from 18mm - 27mm)(10).
- C-Associated cardiac condition requiring concomitant intervention eg severe CAD require CABG ,aneurysm of ascending aorta ,severe mitral or tricuspid valve disease.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03424902
Start Date
September 1 2020
End Date
March 1 2021
Last Update
July 8 2020
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