An observational study in Atrial Fibrillation, sponsored by Saint Luke's Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Saint Luke's Health System · Observational
The objective of this registry is to find out if there is a difference in patient satisfaction and rate of vascular and bleeding complications with use of Perclose Proglide system or F08S for venous closure post atrial fibrillation and atrial flutter procedures in comparison to manual compression.
Vascular Closure Devices (VCD) have been used to achieve hemostasis of arterial access sites following cardiac catheterization procedures. There is extensive literature available supporting the use of these devices for arterial access site closure, showing reduced time to hemostasis, earlier ambulation and reduced length of hospital stay in comparison to manual compression which is the traditional approach to achieve access site hemostasis. In contrast, there is not significant evidence supporting the use of these devices for closure of femoral venous access site, partly due to limited use of VCD in cardiac electrophysiology procedures, such as catheter ablation for atrial fibrillation and atrial flutter. Another alternative to manual compression, the Figure of 8 stitch has also been used to achieve vascular closure follow catheter ablation of atrial fibrillation and atrial flutter, however it has not been studied formally.
The aim of this registry is to better understand the 'real-world' utilization of VCD or Figure of 8 stitch(F08S) in cardiac ablation procedures and to understand any potential difference between VCD or F08S and manual compression. The outcomes of interest are vascular access site complication rate, time to ambulation and patient perception of pain and overall satisfaction, which is assessed via a survey. The hypothesis of this registry is that there will be an increased patient satisfaction and decreased rate of vascular and bleeding complications with use of either Perclose Proglide system or Figure of 8 stitch for venous closure post atrial fibrillation ablation and atrial flutter ablation procedures in comparison to standard manual compression.
The design will be a prospective observational registry collecting data on patients who underwent catheter ablation for atrial fibrillation and atrial flutter, including administration of a patient survey.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 434 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Saint Luke's Health System is the lead sponsor of 35 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing a catheter ablation procedure (radiofrequency ablation or cryoablation) to treat symptomatic paroxysmal atrial fibrillation or atrial flutter at Saint Luke's Hospital of Kansas City
Exclusion Criteria:
Hemostasis
Time to achieve hemostasis measured in minutes
Time frame: 2 days
Ambulation
Time to ambulate following hemostasis measured in hours
Time frame: 2 days
Complications
Number of bleeding and vascular complications
Time frame: 2 days
Hospital Stay
Length of hospital stay in hours
Time frame: 2 days
| Milestone | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Started | 203 | 156 | 75 |
| Completed | 203 | 156 | 75 |
| Not completed | 0 | 0 | 0 |
Time to achieve hemostasis measured in minutes
| minutes | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Hemostasis | 9 (7 to 12.1) | 20 (15 to 20) | 7 (4 to 10.1) |
Time to ambulate following hemostasis measured in hours
| Hours | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Ambulation | 2.2 (1.3 to 3.5) | 6.5 (5.1 to 7.8) | 2.2 (1.4 to 3.5) |
Number of bleeding and vascular complications
| Participants | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Complications | 3 | 5 | 3 |
Length of hospital stay in hours
| hours | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Hospital Stay | 29 (26 to 30) | 29 (28 to 30) | 27.5 (25 to 29) |
Patient's perception of pain is measured using a 5 point Likert scale, range from 1 to 5 with higher scores indicating higher level of pain
| units on a scale | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Perception of Pain | 4 (2 to 5) | 4 (2 to 5) | 4 (2 to 5) |
Patient satisfaction is measured using a 5 point Likert scale with range from 1 to 5 with higher scores indicating greater patient satisfaction
| units on a scale | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Patient Satisfaction | 5 (4 to 5) | 5 (4 to 5) | 5 (4 to 5) |
Patient's need for manual compression is expressed as number of patients as a whole number
| Participants | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Need for Manual Compression | 3 | 4 | 1 |
Use of protamine sulfate is expressed as a whole number
| Participants | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| Use of Protamine Sulfate | 182 | 19 | 2 |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Figure of 8 | 0/203 (0%) | 0/203 (0%) | 3/203 (1.5%) |
| Manual Compression | 0/156 (0%) | 1/156 (0.6%) | 4/156 (2.6%) |
| Perclose Device | 0/75 (0%) | 0/75 (0%) | 3/75 (4%) |
| Event | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| HematomaVascular disorders | 0/203 | 1/156 | 0/75 |
| Event | Figure of 8 | Manual Compression | Perclose Device |
|---|---|---|---|
| HematomaVascular disorders | 3/203 | 4/156 | 3/75 |
| Age, Continuous(years) | Figure of 8 | Manual Compression | Perclose Device | Total |
|---|---|---|---|---|
| Mean | 63.34 ± 11.0 | 64.51 ± 11.0 | 66.20 ± 11.0 | 64.0 ± 11.0 |
| Sex: Female, Male(Participants) | Figure of 8 | Manual Compression | Perclose Device | Total |
|---|---|---|---|---|
| Female | 80 | 58 | 33 | 171 |
| Male | 123 | 98 | 42 | 263 |
| Race and Ethnicity Not Collected(Participants) | Figure of 8 | Manual Compression | Perclose Device | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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