Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atrial Fibrillation with femoral closure using closing system, Atrial Fibrillation with femoral closure using figure-of-eight stitch.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
Overview
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.
Interventions
- Procedure Atrial Fibrillation with femoral closure using closing system
The ablation procedure will be performed under deep sedation/general anaesthesia as standard of care. Vital signs will be monitored. For patients on oral anticoagulation, the procedure will be performed according to the latest guidelines. For catheter access, sheaths will be placed in the femoral veins after ultrasound-guided puncture according to institutional standard. If the patient is randomised to the SDD group prior to the procedure, the femoral access will be closed with a closure system. - Procedure Atrial Fibrillation with femoral closure using figure-of-eight stitch
The ablation procedure will be performed under deep sedation/general anaesthesia as standard of care. Vital signs will be monitored. For patients on oral anticoagulation, the procedure will be performed according to the latest guidelines. For catheter access, sheaths will be placed in the femoral veins after ultrasound-guided puncture according to institutional standard. If the patient is randomised to the ONS group prior to the procedure, the femoral access will be closed with a figure-of-eight
Primary outcome measures
- 30 Day vascular access-related adverse events [Time frame: 30 days post intervention]
- Time to ambulation [Time frame: 2 Days after intervention]
Secondary outcome measures (2)
- Quality of Life assessment - EQ-5D-5L [Time frame: 12 Month after Intervention]
- Quality of Life assessment - AFEQT [Time frame: 12 Month after Intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Klinik für Rhythmologie — Lübeck
Identifiers
NCT: NCT06598280 · SHAzAM-AF