Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, vascular closure
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Abbott Medical Devices
Saint Luke's Health System
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a catheter ablation procedure (radiofrequency ablation or cryoablation) to treat symptomatic paroxysmal atrial fibrillation or atrial flutter * Patients willing to participate in a short written survey
Exclusion criteria
* Patients undergoing ablation for an arrhythmia other than atrial fibrillation/atrial flutter or who are not candidates for an ablation procedure for treatment of atrial fibrillation/atrial flutter * Patients who are not able to read or understand the English language * Patients who had recent access site complications within the same hospitalization * Patients who have baseline thrombocytopenia (platelet count less than 80) or known coagulopathy (INR \> 1.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis | 2 days | Time to achieve hemostasis measured in minutes |
| Ambulation | 2 days | Time to ambulate following hemostasis measured in hours |
| Complications | 2 days | Number of bleeding and vascular complications |
| Hospital Stay | 2 days | Length of hospital stay in hours |
Countries
United States
Participant flow
Pre-assignment details
Because this is a registry, there are no randomization procedures. The choice of closure method was chosen by each subject's physicians. The subjects were approached for consent after the procedure.
Participants by arm
| Arm | Count |
|---|---|
| Figure of 8 Figure of 8 stitch is used for venous closure post atrial fibrillation and atrial flutter procedures | 203 |
| Manual Compression Manual compression is used to achieve hemostasis after atrial fibrillation and atrial flutter procedures | 156 |
| Perclose Device Perclose Proglide system is used for venous closure post atrial fibrillation and atrial flutter procedures | 75 |
| Total | 434 |
Baseline characteristics
| Characteristic | Figure of 8 | Manual Compression | Perclose Device | Total |
|---|---|---|---|---|
| Age, Continuous | 63.34 years STANDARD_DEVIATION 11 | 64.51 years STANDARD_DEVIATION 11 | 66.20 years STANDARD_DEVIATION 11 | 64.0 years STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 80 Participants | 58 Participants | 33 Participants | 171 Participants |
| Sex: Female, Male Male | 123 Participants | 98 Participants | 42 Participants | 263 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 156 | 0 / 75 |
| other Total, other adverse events | 3 / 203 | 4 / 156 | 3 / 75 |
| serious Total, serious adverse events | 0 / 203 | 1 / 156 | 0 / 75 |
Outcome results
Primary
Ambulation
Time to ambulate following hemostasis measured in hours
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Figure of 8 | Ambulation | 2.2 Hours |
| Manual Compression | Ambulation | 6.5 Hours |
| Perclose Device | Ambulation | 2.2 Hours |
Primary
Complications
Number of bleeding and vascular complications
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Figure of 8 | Complications | 3 Participants |
| Manual Compression | Complications | 5 Participants |
| Perclose Device | Complications | 3 Participants |
Primary
Hemostasis
Time to achieve hemostasis measured in minutes
Time frame: 2 days
Population: There were 434 patients included
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Figure of 8 | Hemostasis | 9 minutes |
| Manual Compression | Hemostasis | 20 minutes |
| Perclose Device | Hemostasis | 7 minutes |
Primary
Hospital Stay
Length of hospital stay in hours
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Figure of 8 | Hospital Stay | 29 hours |
| Manual Compression | Hospital Stay | 29 hours |
| Perclose Device | Hospital Stay | 27.5 hours |
Post Hoc
Need for Manual Compression
Patient's need for manual compression is expressed as number of patients as a whole number
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Figure of 8 | Need for Manual Compression | 3 Participants |
| Manual Compression | Need for Manual Compression | 4 Participants |
| Perclose Device | Need for Manual Compression | 1 Participants |
Post Hoc
Patient Satisfaction
Patient satisfaction is measured using a 5 point Likert scale with range from 1 to 5 with higher scores indicating greater patient satisfaction
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Figure of 8 | Patient Satisfaction | 5 units on a scale |
| Manual Compression | Patient Satisfaction | 5 units on a scale |
| Perclose Device | Patient Satisfaction | 5 units on a scale |
Post Hoc
Perception of Pain
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
Time frame: 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Figure of 8 | Perception of Pain | 4 units on a scale |
| Manual Compression | Perception of Pain | 4 units on a scale |
| Perclose Device | Perception of Pain | 4 units on a scale |
Post Hoc
Use of Protamine Sulfate
Use of protamine sulfate is expressed as a whole number
Time frame: 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Figure of 8 | Use of Protamine Sulfate | 182 Participants |
| Manual Compression | Use of Protamine Sulfate | 19 Participants |
| Perclose Device | Use of Protamine Sulfate | 2 Participants |