Atrial Fibrillation
Conditions
Keywords
Cardiology, Electrophysiology
Brief summary
This a prospective randomized trial occurring in patients undergoing routine ablation for atrial fibrillation as standard of care. The purpose of this study is to determine if using a small internal suture (or stitch) facilitates faster times to hemostasis (stopping bleeding) after removing intravenous sheaths (special IVs that are used for ablation procedures) after an atrial fibrillation ablation procedure. The device used to place the stitch is PerClose Proglide and is an already FDA-approved technology for closing these IV sites. The study will also determine if it is safe to get up and walk sooner than what is considered typical after closing these IV sites with the PerClose device. Participants will be randomized in a 1:1 ratio to either manual compression or use of the PerClose for hemostasis at the end of the ablation procedure. The length of follow-up will be up to 30 days at routine clinical follow-up after the procedure.
Detailed description
Radiofrequency ablation and cryoablation for treatment of atrial fibrillation (AF) using percutaneous venous access at the groin is one of the most common procedures performed by cardiac electrophysiologists. However, compared to other catheter-based interventions, patients undergoing AF ablation pose a unique set of challenges. First, AF ablation requires multiple points of transfemoral venous access with large diameter sheaths, ranging in size from 8 French gauge (F) to 14F for cryoablation procedures. Second, operators are forced to balance the competing risk of thrombosis and bleeding in these patients. In order to minimize the risk of intraprocedural thrombosis, anticoagulation with heparin with a goal anticoagulation time (ACT) \>300-350 seconds is necessary. However, operators typically require ACTs to normalize prior to removal of sheaths and manual compression, which significantly delays hemostasis and ambulation. While reversal agents are an option, there is currently clinical equipoise on their role and safety in this setting and they require additional time to exert their full effect. Lastly, patients require at least 1-2 months of therapeutic oral anticoagulation after the procedure to mitigate ongoing stroke risk. These factors culminate in longer times to hemostasis and ambulation and raise concerns for post-procedure access related complications for patients undergoing AF ablation. PerClose Proglide has recently gained FDA approval for closure of percutaneous venous access sites for catheter-based interventions and remains the only commercially available solution for access sites \>14F inner diameter. Percutaneous closure of venotomy sites may facilitate rapid hemostasis without the need for reversal of anticoagulation, potentially attenuating bleeding risk. Additionally, typical bedrest times after percutaneous closure are based on data derived from arterial closure. Prior limited data, as well as frequent anecdotal reports, have suggested that earlier ambulation may be feasible. Because the venous circulation is a lower pressure system, it is possible that earlier than standard ambulation times after PerClose is both safe and feasible. However, a rigorous prospective investigation of the PerClose Proglide device in the context of AF ablation has not been performed.
Interventions
DEVICEPercutaneous Closure
The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
OTHERManual Compression
Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without figure of eight suture for hemostasis at the discretion of the treating physician).
Sponsors
Abbott
Michael S. Lloyd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* undergoing elective atrial fibrillation ablation at Emory University Hospital or Emory University Hospital Midtown
Exclusion criteria
* women who are pregnant (based on standard pre-procedure pregnancy test) * patients who are not able to ambulate pre-procedure * patients who are unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | Day 1 | Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | Day 1 | Time to ambulation (in minutes) following the atrial fibrillation ablation, will be compared between study arms. |
| Number of Complications | Day 30 | Number of complications will be compared between study arms as a composite of all major access site complications and venous thromboembolism. |
| Short-form Inguinal Pain Questionnaire Score | Day 30 | The Short-form Inguinal Pain Questionnaire is a quality of life metric where respondents report how much pain they have experienced in the past week and how pain has limited their activities. The questionnaire consists of two items, each with a score ranging from 0 to 6. Question 1 asks participants to report the worst pain they have experienced in the past week, where responses range from 0 (no pain) to 6 (pain present, prompt medical advice sought). If participants have experienced pain, Question 2 asks what limitations the pain has caused in performing everyday activities such as sitting down, standing up, or exercising. The total score for question 2 ranges from 0 (none of the listed activities were impacted) to 6 (all listed activities were impacted). |
| Procedure Length | Day 1 | The length of the procedure to reach hemostasis, in minutes, will be compared between study arms. |
| Patient Satisfaction | Day 1 and Day 30 | Patient satisfaction was assessed with a 6-item instrument where participants responded on a scale from 0 to 5 where 0 = completely satisfied and 5 = completely dissatisfied. The sum of scores can range from 0 to 30 and lower scores indicate greater satisfaction with pain level and appearance of the access site. Measurements were taken at discharge (day 1) and the same instrument was used on follow up (day 30). |
| Pain Medication Needs | Day 1 | Post-procedure narcotic usage for pain medication requirements after hemostasis until discharge from the post-procedure area will be compared between study arms. |
| Costs | Day 30 | Overall costs (in dollars) related to hemostasis and any complications over 30 days will be compared between study arms. |
| Number of Nursing Encounters | Day 1 | The number of nursing encounters while in the post-procedure area will be compared between study arms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Percutaneous Closure Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Percutaneous Closure: The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation. | 55 |
| Manual Compression Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Manual Compression: Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without figure of eight suture for hemostasis at the discretion of the treating physician). | 54 |
| Total | 109 |
Baseline characteristics
| Characteristic | Percutaneous Closure | Manual Compression | Total |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 10 | 64.3 years STANDARD_DEVIATION 11.5 | 62.7 years STANDARD_DEVIATION 10.8 |
| Baseline anticoagulation Apixaban | 36 Participants | 35 Participants | 71 Participants |
| Baseline anticoagulation Aspirin | 10 Participants | 9 Participants | 19 Participants |
| Baseline anticoagulation Clopidogrel/P2Y12 inhibitor | 1 Participants | 0 Participants | 1 Participants |
| Baseline anticoagulation Dabigatran | 1 Participants | 0 Participants | 1 Participants |
| Baseline anticoagulation None | 3 Participants | 5 Participants | 8 Participants |
| Baseline anticoagulation Rivaroxaban | 8 Participants | 10 Participants | 18 Participants |
| Baseline anticoagulation Warfarin | 4 Participants | 3 Participants | 7 Participants |
| Medical History Cancer | 8 Participants | 5 Participants | 13 Participants |
| Medical History Cerebrovascular Disease | 2 Participants | 3 Participants | 5 Participants |
| Medical History Congestive Heart Failure | 7 Participants | 5 Participants | 12 Participants |
| Medical History Coronary Artery Disease | 6 Participants | 13 Participants | 19 Participants |
| Medical History Current or ex-smoker | 19 Participants | 14 Participants | 33 Participants |
| Medical History Deep Vein Thrombosis | 0 Participants | 1 Participants | 1 Participants |
| Medical History Diabetes | 6 Participants | 5 Participants | 11 Participants |
| Medical History Hypercholesterolemia | 17 Participants | 20 Participants | 37 Participants |
| Medical History Hypertension | 33 Participants | 30 Participants | 63 Participants |
| Medical History Peripheral Vascular Disease | 3 Participants | 2 Participants | 5 Participants |
| Medical History Prior groin access procedure | 18 Participants | 21 Participants | 39 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 54 Participants | 54 Participants | 108 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 48 Participants | 97 Participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 39 Participants | 36 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 54 |
| other Total, other adverse events | 4 / 53 | 12 / 54 |
| serious Total, serious adverse events | 2 / 53 | 1 / 54 |
Outcome results
Primary
Time to Hemostasis
Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms.
Time frame: Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Closure | Time to Hemostasis | 4.5 seconds |
| Manual Compression | Time to Hemostasis | 10.7 seconds |
Secondary
Costs
Overall costs (in dollars) related to hemostasis and any complications over 30 days will be compared between study arms.
Time frame: Day 30
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Percutaneous Closure | Costs | Cost related to Hemostasis | 882 dollars |
| Percutaneous Closure | Costs | Total cost of procedure | 882 dollars |
| Percutaneous Closure | Costs | Total cost of care related to procedure | 57,050.44 dollars |
| Manual Compression | Costs | Cost related to Hemostasis | 4 dollars |
| Manual Compression | Costs | Total cost of procedure | 42 dollars |
| Manual Compression | Costs | Total cost of care related to procedure | 56,533.65 dollars |
Secondary
Number of Complications
Number of complications will be compared between study arms as a composite of all major access site complications and venous thromboembolism.
Time frame: Day 30
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Percutaneous Closure | Number of Complications | Complications at Discharge | 0 Participants |
| Percutaneous Closure | Number of Complications | Complications At follow Up | 0 Participants |
| Manual Compression | Number of Complications | Complications at Discharge | 1 Participants |
| Manual Compression | Number of Complications | Complications At follow Up | 1 Participants |
Secondary
Number of Nursing Encounters
The number of nursing encounters while in the post-procedure area will be compared between study arms.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percutaneous Closure | Number of Nursing Encounters | 0.06 Number of encounters | Standard Deviation 0.231 |
| Manual Compression | Number of Nursing Encounters | 0.09 Number of encounters | Standard Deviation 0.564 |
Secondary
Pain Medication Needs
Post-procedure narcotic usage for pain medication requirements after hemostasis until discharge from the post-procedure area will be compared between study arms.
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Percutaneous Closure | Pain Medication Needs | 8 Participants |
| Manual Compression | Pain Medication Needs | 5 Participants |
Secondary
Patient Satisfaction
Patient satisfaction was assessed with a 6-item instrument where participants responded on a scale from 0 to 5 where 0 = completely satisfied and 5 = completely dissatisfied. The sum of scores can range from 0 to 30 and lower scores indicate greater satisfaction with pain level and appearance of the access site. Measurements were taken at discharge (day 1) and the same instrument was used on follow up (day 30).
Time frame: Day 1 and Day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Percutaneous Closure | Patient Satisfaction | Bruising around your groin area at Discharge | 0.7 score on a scale | Standard Deviation 1.249 |
| Percutaneous Closure | Patient Satisfaction | Pain in your Groin at Discharge | 1.13 score on a scale | Standard Deviation 1.455 |
| Percutaneous Closure | Patient Satisfaction | Bruising around your groin area at Day 30 | 0.73 score on a scale | Standard Deviation 1.44 |
| Percutaneous Closure | Patient Satisfaction | Tenderness around your groin at Day 30 | 0.84 score on a scale | Standard Deviation 1.546 |
| Percutaneous Closure | Patient Satisfaction | Problems in your groin where the catheter was inserted at Discharge | 0.49 score on a scale | Standard Deviation 0.869 |
| Percutaneous Closure | Patient Satisfaction | Pain in your Groin at Day 30 | 0.59 score on a scale | Standard Deviation 1.206 |
| Percutaneous Closure | Patient Satisfaction | Problems in your groin where the catheter was inserted at Day 30 | 0.29 score on a scale | Standard Deviation 0.913 |
| Percutaneous Closure | Patient Satisfaction | Numbness in your groin area at Discharge | 0.42 score on a scale | Standard Deviation 0.719 |
| Percutaneous Closure | Patient Satisfaction | Appearance of your bruise at Discharge | 0.64 score on a scale | Standard Deviation 1.128 |
| Percutaneous Closure | Patient Satisfaction | Appearance of your bruise at Day 30 | 0.8 score on a scale | Standard Deviation 1.581 |
| Percutaneous Closure | Patient Satisfaction | Numbness in your groin area at Day 30 | 0.29 score on a scale | Standard Deviation 0.764 |
| Percutaneous Closure | Patient Satisfaction | Sum of Scores | 4.58 score on a scale | Standard Deviation 4.99 |
| Percutaneous Closure | Patient Satisfaction | Tenderness around your groin at Discharge | 1.21 score on a scale | Standard Deviation 1.405 |
| Manual Compression | Patient Satisfaction | Sum of Scores | 2.96 score on a scale | Standard Deviation 4.813 |
| Manual Compression | Patient Satisfaction | Pain in your Groin at Day 30 | 0.25 score on a scale | Standard Deviation 0.845 |
| Manual Compression | Patient Satisfaction | Tenderness around your groin at Discharge | 0.65 score on a scale | Standard Deviation 1.067 |
| Manual Compression | Patient Satisfaction | Tenderness around your groin at Day 30 | 0.49 score on a scale | Standard Deviation 1.084 |
| Manual Compression | Patient Satisfaction | Numbness in your groin area at Discharge | 0.3 score on a scale | Standard Deviation 0.743 |
| Manual Compression | Patient Satisfaction | Numbness in your groin area at Day 30 | 0.08 score on a scale | Standard Deviation 0.392 |
| Manual Compression | Patient Satisfaction | Bruising around your groin area at Discharge | 0.52 score on a scale | Standard Deviation 1.077 |
| Manual Compression | Patient Satisfaction | Bruising around your groin area at Day 30 | 0.84 score on a scale | Standard Deviation 1.488 |
| Manual Compression | Patient Satisfaction | Problems in your groin where the catheter was inserted at Discharge | 0.37 score on a scale | Standard Deviation 0.938 |
| Manual Compression | Patient Satisfaction | Problems in your groin where the catheter was inserted at Day 30 | 0.37 score on a scale | Standard Deviation 0.937 |
| Manual Compression | Patient Satisfaction | Appearance of your bruise at Discharge | 0.41 score on a scale | Standard Deviation 0.962 |
| Manual Compression | Patient Satisfaction | Appearance of your bruise at Day 30 | 0.92 score on a scale | Standard Deviation 1.719 |
| Manual Compression | Patient Satisfaction | Pain in your Groin at Discharge | 0.72 score on a scale | Standard Deviation 1.14 |
Secondary
Procedure Length
The length of the procedure to reach hemostasis, in minutes, will be compared between study arms.
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Percutaneous Closure | Procedure Length | Initial Stick to Out of Lab | 158.06 minutes | Standard Deviation 35.653 |
| Percutaneous Closure | Procedure Length | Initial Stick to complete hemostasis | 141.81 minutes | Standard Deviation 35.401 |
| Manual Compression | Procedure Length | Initial Stick to Out of Lab | 156.83 minutes | Standard Deviation 54.346 |
| Manual Compression | Procedure Length | Initial Stick to complete hemostasis | 146.15 minutes | Standard Deviation 53.805 |
Secondary
Short-form Inguinal Pain Questionnaire Score
The Short-form Inguinal Pain Questionnaire is a quality of life metric where respondents report how much pain they have experienced in the past week and how pain has limited their activities. The questionnaire consists of two items, each with a score ranging from 0 to 6. Question 1 asks participants to report the worst pain they have experienced in the past week, where responses range from 0 (no pain) to 6 (pain present, prompt medical advice sought). If participants have experienced pain, Question 2 asks what limitations the pain has caused in performing everyday activities such as sitting down, standing up, or exercising. The total score for question 2 ranges from 0 (none of the listed activities were impacted) to 6 (all listed activities were impacted).
Time frame: Day 30
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Percutaneous Closure | Short-form Inguinal Pain Questionnaire Score | Worst pain felt in the groin over the past 7 days | 0 score on a scale |
| Percutaneous Closure | Short-form Inguinal Pain Questionnaire Score | Extent of limitation of ability to perform different activities by groin pain | 0 score on a scale |
| Manual Compression | Short-form Inguinal Pain Questionnaire Score | Worst pain felt in the groin over the past 7 days | 0 score on a scale |
| Manual Compression | Short-form Inguinal Pain Questionnaire Score | Extent of limitation of ability to perform different activities by groin pain | 0 score on a scale |
Secondary
Time to Ambulation
Time to ambulation (in minutes) following the atrial fibrillation ablation, will be compared between study arms.
Time frame: Day 1
Population: Of those in the Percutaneous Closure group (n=53), two patients were excluded as they had crossed over to full MC, and 5 others did not undergo secondary randomization due to lack of research staff or logistic challenges. Secondary randomization for six others was deferred at the discretion of the treating provider. Number of those who underwent secondary randomization (n=40).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percutaneous Closure | Time to Ambulation | 1.33 Hours |
| Manual Compression | Time to Ambulation | 2.25 Hours |