Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
- Conditions
- Aortic Valve StenosisHeart Valve DiseasesAortic Valve Disease
- Interventions
- Device: TF TAVI
- Registration Number
- NCT05758909
- Lead Sponsor
- Fundación EPIC
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 585
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving transfemoral (TF) TAVI TF TAVI TF TAVI
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Assessment of Hospitalization for any reason 12 months Incidence of patients with Hospitalization for any reason according to VARC 3 criteria
Assessment of Myocardial Infarction 12 months Incidence of patients with Myocardial Infarction diagnosed by Cardiologist according to VARC 3 criteria
Assessment of Stroke 12 months Incidence of patients with stroke diagnosed by a Neurologist according to VARC 3 criteria
Assessments of need for pacemakers 12 months Incidence of patients with need for pacemakers according to VARC 3 criteria
Assessment of Cardiovascular death 12 months Assessment of Cardiovascular death
Assessments of Major Vascular Complications 12 months Incidence of patients with Major Vascular Complications 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 30 days Incidence of patients with hospitalization due cardiac reasons according to VARC 3 criteria
Trial Locations
- Locations (13)
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Spain
Hospital Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
Hospital Clinico San Carlos
🇪🇸Aravaca, Spain
Hospital Universitari Germans Trias I Pujol
🇪🇸Badalona, Spain
Hospital de Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitari Vall Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Universitari i Politècnic la Fe
🇪🇸Valencia, Spain