Comparison of Percutaneous Closure to Manual Compression for Hemostasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Comparison of Percutaneous Closure to Manual Compression for Hemostasis of Multiple Venous Access Sites Among Patients Undergoing Catheter Ablation for Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Percutaneous Closure
* Other: Manual Compression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Closure<br>Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation. | Device: Percutaneous Closure<br>* 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.<br>* Other names: PerClose Proglide;|
| Active Comparator: Manual Compression<br>Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation. | Other: Manual Compression<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Hemostasis | Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation | Time to ambulation (in minutes) following the atrial fibrillation ablation, will be compared between study arms. | Day 1 | 
| Number of Complications | Number of complications will be compared between study arms as a composite of all major access site complications and venous thromboembolism. | Day 30 | 
| 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). | Day 30 | 
| Procedure Length | The length of the procedure to reach hemostasis, in minutes, will be compared between study arms. | Day 1 | 
| 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). | Day 1 and Day 30 | 
| 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. | Day 1 | 
| Costs | Overall costs (in dollars) related to hemostasis and any complications over 30 days will be compared between study arms. | Day 30 | 
| Number of Nursing Encounters | The number of nursing encounters while in the post-procedure area will be compared between study arms. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiology, Electrophysiology