Comparing same-day discharge to overnight stay after heart procedure for atrial fibrillation
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
This study is testing if patients with atrial fibrillation can safely go home the same day after a heart procedure instead of staying overnight, to see if it makes them more comfortable and lowers healthcare costs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Luebeck Academic / other |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Trial ID | NCT06598280 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, randomized, controlled, multicenter trial that aims to compare the safety and efficacy of a Same Day Discharge (SDD) protocol against the traditional overnight stay (ONS) protocol for patients undergoing pulmonary vein isolation for atrial fibrillation. It will utilize a suture-mediated vascular closure device and assess the rates of adverse events, unplanned medical visits, and readmissions over a 30-day period, while also evaluating the protocol's safety and feasibility during a 12-month follow-up. The goal is to demonstrate that SDD can provide similar safety outcomes while reducing healthcare costs and enhancing patient comfort.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective catheter ablation for atrial fibrillation.
Not a fit: Patients with active infections, certain blood disorders, or extreme body mass index may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow patients to recover at home sooner, improving comfort and reducing hospital costs.
How similar studies have performed: Other studies have shown promising results with same-day discharge protocols in similar procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients age \>=18 years * Elective catheter ablation for atrial fibrillation using 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites, independent of the energy source use Exclusion Criteria: * Active systemic or cutaneous infection, or inflammation in vicinity of the groin * Platelet count \< 50,000 cells/mm3 * Body mass index (BMI) \> 45 kg/m2 or \< 18 kg/m2
Where this trial is running
Lübeck, Schleswig-Holstein
- Klinik für Rhythmologie — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Principal investigator: Roland R Tilz, Prof. Dr. — Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
- Study coordinator: Roland R Tilz, Prof. Dr.
- Email: roland.tilz@uksh.de
- Phone: 0049451500
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.