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

April 4, 2025 updated by: Roland Richard Tilz, MD, University of Luebeck

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Klinik für Rhythmologie
        • Contact:
        • Contact:
        • Contact:
          • Sorin S Popescu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SDD Group
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
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).
Experimental: ONS Group
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
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
30 Day vascular access-related adverse events
Time Frame: 30 days post intervention
Primary Safety Endpoint
30 days post intervention
Time to ambulation
Time Frame: 2 Days after intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life assessment - EQ-5D-5L
Time Frame: 12 Month after Intervention
Secondary Efficacy Endpoint quality of life assessment (QoL) using the EQ-5D-5L questionnaire which contains 5 questions on current well-being and a scale from 0-100 on the personal assessment of the state of current health (from 0 (very poor) to 100 (very good)).
12 Month after Intervention
Quality of Life assessment - AFEQT
Time Frame: 12 Month after Intervention
Secondary Efficacy Endpoint quality of life assessment (QoL) using the AFEQT questionnaire. which contains 20 questions on 7-point Likert scale on current well-being. Finally, a score between 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered) of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered)
12 Month after Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Luebeck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roland R Tilz, Prof. Dr., Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHAzAM-AF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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