Status:
UNKNOWN
Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
Lead Sponsor:
Assiut University
Conditions:
TAVI
Eligibility:
All Genders
Phase:
NA
Brief Summary
Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
Detailed Description
The method of transcatheter aortic valve implantation (TAVI) which was introduced in 2002 by Alain Cribier et al. has offered new prospects for patients with severe aortic stenosis and multiple comorb...
Eligibility Criteria
Inclusion
- 1- Intermediate or high risk patient for surgical aortic valve replacement ,EuroSCORE \>15% or an STS score \>10%. (13)
- 2- Transfermoral approach.
- 2- Contraindications for open chest surgery, such as(14) :
- Expected high perioperative risk due to comorbidities not adequately reflected by scores :
- 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.
- Patients with previously implanted Permenant Pacemakers.
- 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)(14).
- Elevated risk of coronary ostium obstruction (asymmetric valve calcification, short distance between annulus and coronary ostium, small aortic sinuses).
- Plaques with mobile thrombi in the ascending aorta, or arch. For transfemoral/subclavian approach: inadequate vascular access (vessel size, calcification, tortuosity).
- left Ventricular Thrombus.
- C-Severe primary associated disease of other valves or significant coronary artery disease with major contribution to the patient's symptoms that can be treated only by surgery.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04083040
Start Date
December 1 2019
End Date
May 1 2021
Last Update
September 10 2019
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