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SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients

RECRUITINGN/ASponsored by Maria Cecilia Hospital
Actively Recruiting
PhaseN/A
SponsorMaria Cecilia Hospital
Started2022-09-26
Est. completion2025-12
Eligibility
Age18 Years – 83 Years
Healthy vol.Accepted

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

Age: 18 Years – 83 YearsHealthy volunteers accepted
Inclusion Criteria:

1. Age \>=18 and =\< 83 years
2. Normal PR interval at 12-lead electrocardiogram (ECG)
3. No evidence of Right bundle branch block (RBBB) or high-degree Atrioventricular Block ( AV) blocks at 12-lead ECG
4. eGFR \> 50 ml/min/1.73 m2
5. Ilio-femoral anatomy compatible with transfemoral transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

1. Inability to provide informed consent
2. Not suitable anatomy for transfemoral access
3. Need for general anaesthesia (e.g. hemodynamic instability)
4. Bicuspid aortic valve anatomy
5. Severely impaired left ventricular ejection fraction (LVEF \<35%)
6. At least moderate mitral regurgitation
7. Non-cardiac illness with a life expectancy of less than 1 year
8. Currently participating in another trial before reaching first endpoint.

Conditions2

Heart DiseaseStenoses, Aortic

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