Clinical trial NCT06598280: Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
Official title: Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The aim of the study is to prove that the use of a SDD protocol does not lead to a higher rate of adverse events (minor and major), unplanned medical visits (emergency department or outpatients' clinic) and unplanned readmissions, while substantially reducing the costs associated with the medical care and increasing the comfort of the patients on a period of 30 days, when compared to ONS and manual compression ± figure-of-eight suture. Moreover, the safety, efficiency, and feasibility of the SDD protocol should be proven during a follow-up (FU) period of 12 months. The definition of endpoints will be trained in all participating study sites to preserve consistency.

Eligibility 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

Primary outcomes:
measure: 30 Day vascular access-related adverse events
timeFrame: 30 days post intervention
measure: Time to ambulation
timeFrame: 2 Days after intervention
Secondary outcomes:
measure: Quality of Life assessment - EQ-5D-5L
timeFrame: 12 Month after Intervention
measure: Quality of Life assessment - AFEQT
timeFrame: 12 Month after Intervention
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Klinik für Rhythmologie
state: Schleswig-Holstein
Study officials:
affiliation: Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
name: Roland R Tilz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
name: Sorin S Popescu, M.D.
role: STUDY_CHAIR
affiliation: Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie, Studienzentrale
name: Mirco Kuechler, M.Sc.
role: STUDY_CHAIR
References: