Status:
RECRUITING
SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients
Lead Sponsor:
Maria Cecilia Hospital
Conditions:
Stenoses, Aortic
Eligibility:
All Genders
18-83 years
Phase:
NA
Brief 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...
Detailed Description
In most cases, prolongation of hospital stay is mainly related to electrical, renal, vascular or neurological complications. With increasing operators' experience, careful procedure planning and techn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05983458
Start Date
September 26 2022
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48033