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

NCT06598280 | Recruiting DMC

• 1 other identifier: SHAzAM-AF
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 30 Day vascular access-related adverse events

  Primary Safety Endpoint

  30 days post intervention

• Time to ambulation

  Primary Efficacy Endpoint elapsed time between removal of the final closure device or removal of final sheath and the moment when the patient stood and walked 20 ft without evidence of venous re-bleeding from the femoral access site (time to ambulation; TTA)

  2 Days after intervention

Secondary Outcomes (2)

• Quality of Life assessment - EQ-5D-5L

  12 Month after Intervention

• Quality of Life assessment - AFEQT

  12 Month after Intervention

Study Arms (2)

SDD Group

EXPERIMENTAL

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.

Procedure: Atrial Fibrillation with femoral closure using closing system

ONS Group

EXPERIMENTAL

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.

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

Interventions

Atrial Fibrillation with femoral closure using closing system PROCEDURE

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. Ablation technique, number of access points and procedural details will be performed according to institutional standard. Patients may be enrolled regardless of the energy source used for ablation. The minimum procedural endpoint is PVI. Ablation strategies in addition to PVI are at the discretion of the operator. Antiarrhythmic therapy may be administered for a maximum of 2 months (blanking period).

SDD Group

Atrial Fibrillation with femoral closure using figure-of-eight stitch PROCEDURE

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 suture. The ablation technique, number of access points and procedural details will be performed according to institutional standard. Patients may be enrolled regardless of the energy source used for ablation. The minimum procedural endpoint is PVI. Ablation strategies in addition to PVI are at the discretion of the operator. Antiarrhythmic therapy may be administered for a maximum of 2 months (blanking period).

ONS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Klinik für Rhythmologie

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland R Tilz, Prof. Dr.

  Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie

  PRINCIPAL INVESTIGATOR

• Sorin S Popescu, M.D.

  Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie

  STUDY CHAIR

• Mirco Kuechler, M.Sc.

  Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie, Studienzentrale

  STUDY CHAIR

Central Study Contacts

Roland R Tilz, Prof. Dr.

CONTACT

0049451500; roland.tilz@uksh.de

Sorin S Popescu, MD

CONTACT

0049451500; sorinstefan.popescu@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. univ. med.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: September 19, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 15, 2028
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

DE (1)