Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
Style-AF
1 other identifier
interventional
125
1 country
3
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Nov 2022
Shorter than P25 for not_applicable atrial-fibrillation
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
October 3, 2022
CompletedStudy Start
First participant enrolled
November 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedJuly 1, 2024
June 1, 2024
1.3 years
September 27, 2022
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 hours
Secondary Outcomes (8)
total post procedure time
6 hours
time to hemostasis
6 hours
time to discharge eligibility
3 days
time to discharge
3 days
time to closure eligibility
6 hours
- +3 more secondary outcomes
Study Arms (2)
Group Perclose ProStyle closure
EXPERIMENTAL50 patients treated with Perclose ProStyle suture-mediated closure device to achieve hemostasis
Group manual compression
ACTIVE COMPARATOR50 patients treated with manual compression and one figure of eight suture
Interventions
patients will be randomized to either group 1 or group 2 in a 1:1 ratio:
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Klinik für Innere Medizin III
Kiel, Schleswig-Holstein, 24105, Germany
Klinik für Rhythmologie
Lübeck, Schleswig-Holstein, 23538, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Clinical Professor, Head of Rhythmology
Study Record Dates
First Submitted
September 27, 2022
First Posted
October 3, 2022
Study Start
November 22, 2022
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
July 1, 2024
Record last verified: 2024-06