SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients
Safe and Fast Discharge With Acurate Valve in Low Risk Tavi Patients
Maria Cecilia Hospital
80 participants
Sep 26, 2022
INTERVENTIONAL
Conditions
Summary
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges
Eligibility
Inclusion Criteria5
- Age >=18 and =< 83 years
- Normal PR interval at 12-lead electrocardiogram (ECG)
- No evidence of Right bundle branch block (RBBB) or high-degree Atrioventricular Block ( AV) blocks at 12-lead ECG
- eGFR > 50 ml/min/1.73 m2
- Ilio-femoral anatomy compatible with transfemoral transcatheter aortic valve implantation (TAVI)
Exclusion Criteria8
- Inability to provide informed consent
- Not suitable anatomy for transfemoral access
- Need for general anaesthesia (e.g. hemodynamic instability)
- Bicuspid aortic valve anatomy
- Severely impaired left ventricular ejection fraction (LVEF <35%)
- At least moderate mitral regurgitation
- Non-cardiac illness with a life expectancy of less than 1 year
- Currently participating in another trial before reaching first endpoint.
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Interventions
TAVI procedure will be performed under conscious sedation. Foley urinary catheters and jugular lines will be avoided. For femoral access, closure devices will be Prostar or ProGlide, which are similar and carry low rates of major vascular complications . Single femoral access and a radial access as the secondary arterial access will be used to reduce the rate of vascular complications. All procedures will be performed with cerebral protection using the Sentinel device. During valve implantation, commissural alignment will be checked for all patients. As a practical rule, commissural alignment will be checked in co-planar view and in cusp-overlap view.
Locations(1)
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NCT05983458