Comparing same-day discharge to overnight stay after heart procedure for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.