Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation

Официальное название

Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

• 30 Day vascular access-related adverse events [Срок оценки: 30 days post intervention]
• Time to ambulation [Срок оценки: 2 Days after intervention]

Вторичные конечные точки (2)

• Quality of Life assessment - EQ-5D-5L [Срок оценки: 12 Month after Intervention]
• Quality of Life assessment - AFEQT [Срок оценки: 12 Month after Intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Klinik für Rhythmologie — Lübeck

Идентификаторы

NCT: NCT06598280 · SHAzAM-AF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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