NCT06598280Recruiting
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Prospective, randomized, controlled, multicentre study to compare the safety and efficacy of a Same Day Discharge (SDD) protocol in combination with a Perclose ProStyle (PPS) /ProGlide (PPG) suture mediated vascular closure device to the current gold standard: an overnight stay (ONS) protocol associated with manual compression ± figure-of-eight suture for the patients receiving interventional pulmonary vein isolation (PVI).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 12 Jul 2024
- Start date
- 20 Feb 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Luebeck
- Diseases
- Atrial fibrillation
- NCT number
- NCT06598280
What you commit to
- Study type: Interventional
- Planned participants: 270
- From 20 Feb 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
Lab values
- Platelet count \< 50,000 cells/mm3
Other
- Body mass index (BMI) \> 45 kg/m2 or \< 18 kg/m2
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik für Rhythmologie Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.