Aortic Valve Disease, Aortic Valve Stenosis, Heart Valve Diseases
Conditions
Brief summary
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
Detailed description
Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).
Interventions
DEVICETF TAVI
Follow-up Observation of patients having received a TF-TAVI
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of early safety | 30 days | Proportion of patients with early safety defined as: * Cardiovascular death. * Stroke. * Myocardial Infarction. * Hospitalization for any reason . * Major vascular complications. * Need for pacemakers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Stroke | 30 days | Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria |
| Assessment of Myocardial Infarction | 30 days | Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria |
| Assessment of Hospitalization for any reason | 30 days | Incidence of patients with Hospitalization for any reason according to VARC 3 criteria |
| Assessment of Cardiovascular death | 30 days | Assessment of Cardiovascular death |
| Assessments of need for pacemakers | 30 days | Incidence of patients with need for pacemakers according to VARC 3 criteria |
| Assessment of hospitalization time | at discharge | Incidence of patients with hospitalization according to VARC 3 criteria |
| Assessment of hospitalization due cardiac reasons | 12 months | Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria |
| Assessments of Major Vascular Complications | 30 days | Incidence of patients with Major Vascular Complications according to VARC 3 criteria |
Countries
Spain
Outcome results
None listed