Evaluating early discharge after heart valve surgery
Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation
This study tests if patients can safely go home within 24 hours after heart valve surgery using a new method called TAVI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 585 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 13 sites (A Coruña and 12 other locations) |
| Trial ID | NCT05758909 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of discharging patients within 24 hours after undergoing transfemoral transcatheter aortic valve implantation (TAVI). It focuses on patients who are scheduled for outpatient procedures and assesses their recovery and outcomes post-implantation. The study aims to determine if early discharge is a viable option without compromising patient safety. Data will be collected on various health metrics to support the findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for outpatient transfemoral TAVI under superficial sedation or local anesthesia.
Not a fit: Patients with wide QRS complexes or those requiring urgent TAVI implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and reduced hospital stays for patients undergoing TAVI.
How similar studies have performed: While there is limited data on early discharge protocols specifically for TAVI, similar approaches in other cardiac procedures have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
A Coruña and 12 other locations
- Hospital Universitario A Coruña — A Coruña, Spain (Recruiting)
- Hospital General Universitario Dr. Balmis — Alicante, Spain (Recruiting)
- Hospital Clinico San Carlos — Aravaca, Spain (Recruiting)
- Hospital Universitari Germans Trias I Pujol — Badalona, Spain (Recruiting)
- Hospital de Santa Creu I Sant Pau — Barcelona, Spain (Recruiting)
- Hospital Universitari Vall Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitario de Bellvitge — Hospitalet de Llobregat, Spain (Recruiting)
- Hospital Regional Universitario de Malaga — Málaga, Spain (Recruiting)
- Hospital Universitario Central de Asturias — Oviedo, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Spain (Recruiting)
- Hospital Clinico Universitario de Santiago — Santiago De Compostela, Spain (Recruiting)
- Hospital Universitario Virgen Del Rocio — Sevilla, Spain (Recruiting)
- Hospital Universitari i Politècnic la Fe — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Vicente Serra Garcia, Md
- Email: vctsrr@hotmail.com
- Phone: 0034932746155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.