NCT05758909
Active, not recruiting
Not Applicable
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
Fundación EPIC13 sites in 1 country585 target enrollmentApril 4, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Disease
- Sponsor
- Fundación EPIC
- Enrollment
- 585
- Locations
- 13
- Primary Endpoint
- Assessment of early safety
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Assessment of early safety
Time Frame: 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 Outcomes
- Assessment of Hospitalization for any reason(12 months)
- Assessment of Stroke(12 months)
- Assessment of Myocardial Infarction(12 months)
- Assessments of need for pacemakers(12 months)
- Assessment of Cardiovascular death(12 months)
- Assessments of Major Vascular Complications(12 months)
- Assessment of hospitalization time(at discharge)
- Assessment of hospitalization due cardiac reasons(30 days)
Study Sites (13)
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