Atrial FibrillationSHAzAM-AFNCT06598280
Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation
A study testing Atrial Fibrillation with femoral closure using closing system and Atrial Fibrillation with femoral closure using figure-of-eight stitch in people with Atrial Fibrillation, run by University of Luebeck at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial Fibrillation with femoral closure using closing system and Atrial Fibrillation with femoral closure using figure-of-eight stitch
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteGermany
- Study dates
- 20 Feb 2025to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Rhythmologie
Lübeck, Schleswig-Holstein, 23538
Roland R Tilz, Prof. Dr. med, 0049451500 ext. 44533, roland.tilz@uksh.de
Mirco Kuechler, 0049451500 ext. 77075, mirco.kuechler@uksh.de
About this study
Official title: 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).
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial Fibrillation with femoral closure using closing system, Atrial Fibrillation with femoral closure using figure-of-eight stitch
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial Fibrillation with femoral closure using closing systemProcedure or surgery
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).
Atrial Fibrillation with femoral closure using figure-of-eight stitchProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Atrial Fibrillation with femoral closure using figure-of-eight stitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 Day vascular access-related adverse events
Primary Safety Endpoint
Measured: 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)
Measured: 2 Days after intervention
Secondary outcomes (2)
Quality of Life assessment - EQ-5D-5L
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)).
Measured: 12 Month after Intervention
Quality of Life assessment - AFEQT
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)
Measured: 12 Month after Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Richard Tilz, MD, University of Luebeck
- Investigators
- Roland R Tilz, Prof. Dr., Principal investigator, Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für RhythmologieSorin S Popescu, M.D., Study chair, Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für RhythmologieMirco Kuechler, M.Sc., Study chair, Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie, Studienzentrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598280
- Sponsor's protocol ID
- SHAzAM-AF
- Acronym
- SHAzAM-AF
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-Day Discharge Versus Overnight Stay Following Pulmonary Vein Isolation for Atrial Fibrillation - the SHAzAM-AF Study
- ClinicalTrials.gov ID
- NCT06598280
- Acronym / sponsor ID
- SHAzAM-AF / SHAzAM-AF
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDD Group | Experimental | Procedure: Atrial Fibrillation with femoral closure using closing systemFollowing 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. |
| ONS Group | Experimental | Procedure: Atrial Fibrillation with femoral closure using figure-of-eight stitchOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial Fibrillation with femoral closure using closing systemThe 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). | Procedure or surgery | SDD Group |
| Atrial Fibrillation with femoral closure using figure-of-eight stitchThe 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). | Procedure or surgery | ONS Group |
Primary outcome
30 Day vascular access-related adverse events
Time frame: 30 days post intervention
Primary Safety Endpoint
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 secondary outcomes
Quality of Life assessment - EQ-5D-5L
Time frame: 12 Month after Intervention
Quality of Life assessment - AFEQT
Time frame: 12 Month after Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland R Tilz, Prof. Dr. principal investigator
Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
Sorin S Popescu, M.D. study chair
Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie
Mirco Kuechler, M.Sc. study chair
Universitätsklinikum Schleswig-Holstein, Universitäres Herzzentrum Lübeck, Klinik für Rhythmologie, Studienzentrale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial Fibrillation with femoral closure using closing system and Atrial Fibrillation with femoral closure using figure-of-eight stitch in people with Atrial Fibrillation, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland R Tilz, Prof. Dr. (0049451500 ext. 44511, roland.tilz@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Day vascular access-related adverse events (time frame: 30 days post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.