Atrial FibrillationStyle-AFNCT05563142
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
A study testing deploying vascular closure device versus manual compression in people with Atrial Fibrillation, run by University of Luebeck at 3 sites in Germany.
Trial summary
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI). 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?
- deploying vascular closure device versus manual compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 3 sitesGermany
- Study dates
- 22 Nov 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites
Who cannot join
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Platelet count < 100,000 cells/mm3
- BMI > 45 kg/m2 or < 20 kg/m2
- Attempted femoral arterial access or inadvertent arterial puncture
- Procedural complications that interfered with routine recovery, ambulation, or discharge times
- Incorrect sheath placement
- Intraprocedural bleeding or thrombotic complications
- Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, 32545
Klinik für Innere Medizin III
Kiel, Schleswig-Holstein, 24105
Klinik für Rhythmologie
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).
Read the detailed description
The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.
- Conditions
- Atrial Fibrillation
- Being tested
- deploying vascular closure device versus manual compression
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deploying vascular closure device versus manual compressionProcedure or surgery
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
| Study group | Role | What they receive |
|---|---|---|
| Group Perclose ProStyle closure | Experimental | 50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis Receives: Procedure: deploying vascular closure device versus manual compression |
| Group manual compression | Active comparator | 50 patients treated with manual compression and one figure of eight suture Receives: Procedure: deploying vascular closure device versus manual compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to ambulation
elapsed time between removal of the final closure device or removal of the final sheath and when the patient can stand and walk 20 ft without evidence of venous re-bleeding from the femoral access site.
Measured: 6 hours
Secondary outcomes (8)
total post procedure time
elapsed time between removal of the last procedural device for the index procedure and when the patient was able to successfully ambulate
Measured: 6 hours
time to hemostasis
elapsed time between removal of the closure device or the sheath and first observed and confirmed venous hemostasis, for each access site
Measured: 6 hours
time to discharge eligibility
elapsed time between removal of the final closure device or final sheath and when the patient was eligible for hospital discharge based solely on the assessment of the access site, as determined by the medical team
Measured: 3 days
time to discharge
elapsed time between removal of the final closure device or final sheath and when the patient was discharged from the institution
Measured: 3 days
time to closure eligibility
elapsed time between removal of the last procedural device for the index procedure and removal of the first closure device or first sheath
Measured: 6 hours
Incidence of major adverse events
Incidence of major adverse events within 30 days after the procedure
Measured: 30 days
Incidence of minor adverse events
Incidence of minor adverse events within 30 days after the procedure
Measured: 30 days
Time to final hemostasis
Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start22 Nov 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Roland Richard Tilz, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563142
- Sponsor's protocol ID
- Style-AF
- Acronym
- Style-AF
- Status last verified
- Jun 2024
- First submitted
- 27 Sep 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tilz RR, Feher M, Vogler J, Bode K, Duta AI, Ortolan A, Lopez LD, Kuchler M, Mamaev R, Lyan E, Sommer P, Braun M, Sciacca V, Demming T, Maslova V, Kuck KH, Heeger CH, Eitel C, Popescu SS. Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study. Europace. 2024 May 2;26(5):euae105. doi: 10.1093/europace/euae105.
PubMed 38647070
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
- ClinicalTrials.gov ID
- NCT05563142
- Acronym / sponsor ID
- Style-AF / Style-AF
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 3 Oct 2022 (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, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).
Detailed description
The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Perclose ProStyle closure | Experimental | Procedure: deploying vascular closure device versus manual compression50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis |
| Group manual compression | Active comparator | Procedure: deploying vascular closure device versus manual compression50 patients treated with manual compression and one figure of eight suture |
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
- Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites
Key exclusion criteria (8 listed)
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Platelet count < 100,000 cells/mm3
- BMI > 45 kg/m2 or < 20 kg/m2
- Attempted femoral arterial access or inadvertent arterial puncture
- Procedural complications that interfered with routine recovery, ambulation, or discharge times
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 |
|---|---|---|
| deploying vascular closure device versus manual compressionpatients will be randomized to either group 1 or group 2 in a 1:1 ratio: | Procedure or surgery | Group Perclose ProStyle closure, Group manual compression |
Primary outcome
Time to ambulation
Time frame: 6 hours
elapsed time between removal of the final closure device or removal of the final sheath and when the patient can stand and walk 20 ft without evidence of venous re-bleeding from the femoral access site.
8 secondary outcomes
total post procedure time
Time frame: 6 hours
time to hemostasis
Time frame: 6 hours
time to discharge eligibility
Time frame: 3 days
time to discharge
Time frame: 3 days
time to closure eligibility
Time frame: 6 hours
Incidence of major adverse events
Time frame: 30 days
Incidence of minor adverse events
Time frame: 30 days
Time to final hemostasis
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 38647070Tilz RR, Feher M, Vogler J, Bode K, Duta AI, Ortolan A, Lopez LD, Kuchler M, Mamaev R, Lyan E, Sommer P, Braun M, Sciacca V, Demming T, Maslova V, Kuck KH, Heeger CH, Eitel C, Popescu SS. Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study. Europace. 2024 May 2;26(5):euae105. doi: 10.1093/europace/euae105.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deploying vascular closure device versus manual compression in people with Atrial Fibrillation, run by University of Luebeck at 3 sites 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 8 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: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ambulation (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563142, which also lists 1 linked publication.
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 1 Jul 2024.