Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation

Study Overview
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Brief Summary
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Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

Detailed Description
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Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

Official Title
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Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation

Conditions
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Aortic Valve Disease, Aortic Valve Stenosis, Heart Valve Diseases

Intervention / Treatment
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* Device: TF TAVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet all of the following conditions will be included: Patients ≥ 18 years undergoing transfemoral TAVI implantation scheduled, performed on an outpatient basis. Patients with percutaneous implant. Patients undergoing the procedure under superficial sedation or Local anesthesia. Patients with baseline narrow QRS that does not change after implantation, or definitive pacemaker carrier. Patients who have signed the informed consent. Exclusion Criteria: Patients who do not meet any of the following conditions: Patients with a wide QRS (greater than or equal to 120 msec) at baseline, with the except for patients with permanent pacemakers. Hospitalized patients undergoing urgent TAVI implantation. Patients with access other than percutaneous transfemoral.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving transfemoral (TF) TAVI<br>TF TAVI | Device: TF TAVI<br>* Follow-up Observation of patients having received a TF-TAVI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of early safety | Proportion of patients with early safety defined as: Cardiovascular death. Stroke. Myocardial Infarction. Hospitalization for any reason . Major vascular complications. Need for pacemakers. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Cardiovascular death | Assessment of Cardiovascular death | 30 days | 
| Assessment of Cardiovascular death | Assessment of Cardiovascular death | 12 months | 
| Assessment of Stroke | Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria | 30 days | 
| Assessment of Stroke | Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria | 12 months | 
| Assessment of Myocardial Infarction | Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria | 30 days | 
| Assessment of Myocardial Infarction | Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria | 12 months | 
| Assessment of Hospitalization for any reason | Incidence of patients with Hospitalization for any reason according to VARC 3 criteria | 30 days | 
| Assessment of Hospitalization for any reason | Incidence of patients with Hospitalization for any reason according to VARC 3 criteria | 12 months | 
| Assessments of Major Vascular Complications | Incidence of patients with Major Vascular Complications according to VARC 3 criteria | 30 days | 
| Assessments of Major Vascular Complications | Incidence of patients with Major Vascular Complications according to VARC 3 criteria | 12 months | 
| Assessments of need for pacemakers | Incidence of patients with need for pacemakers according to VARC 3 criteria | 30 days | 
| Assessments of need for pacemakers | Incidence of patients with need for pacemakers according to VARC 3 criteria | 12 months | 
| Assessment of hospitalization time | Incidence of patients with hospitalization according to VARC 3 criteria | at discharge | 
| Assessment of hospitalization due cardiac reasons | Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria | 12 months | 
| Assessment of hospitalization due cardiac reasons | Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria | 30 days |