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

University of Luebeck

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: Atrial Fibrillation with femoral closure using figure-of-eight stitch; Procedure: Atrial Fibrillation with femoral closure using closing system

Study type: Interventional

Funder types: Other

Identifiers

NCT06598280

SHAzAM-AF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

SDD Group

Experimental group

Description:

Following successful venipuncture, one or two PPS are deployed at the discretion of the operator prior to catheter insertion for catheter sheath sizes ≥ 9 French. Another PPS is deployed after catheter removal if the sheath size is \< 9 French. All sheaths are removed at the end of the ablation procedure. Hemostasis should be achieved by delivery of the suture. Protamine may be administered according to institutional standards. A vertical mattress suture (Donati suture) is applied superficially to conform to the skin tissue. The suture is removed on the first day after PVI.

Treatment:

Procedure: Atrial Fibrillation with femoral closure using closing system

ONS Group

Experimental group

Description:

Once the PVI block is confirmed, a figure-of-eight suture is placed at the femoral access site. The sheaths are removed and haemostasis should be achieved by manual compression at the discretion of the operator. Protamine may be administered according to institutional standards. A tourniquet is applied for a minimum of 30 minutes and the patient should remain supine.

Treatment:

Procedure: Atrial Fibrillation with femoral closure using figure-of-eight stitch