Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture

Study Overview
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Brief Summary
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Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the procedure, heparin is administered to maintain a target ACT > 300 seconds. At the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked 20 later, and if < 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).

Official Title
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Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Ablation for atrial fibrillation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure Exclusion Criteria: Pregnant patients. Age <18 years. Patients who cannot provide consent in English. Prisoners.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Figure of 8 Suture<br>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. | Procedure: Ablation for atrial fibrillation.<br>* Ablation for atrial fibrillation.<br>|
| Active Comparator: Manual Hemostasis Group<br>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. | Procedure: Ablation for atrial fibrillation.<br>* Ablation for atrial fibrillation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Required to Achieve Hemostasis | Time Required to Achieve Hemostasis (minutes) | Time (minutes) from sheath removal till hemostasis achieved | 
| Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab. | Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes) | Time (minutes) from completion of procedure till patient leaves room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group | Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group. | Assessed after sheath removal till patient discharge |