Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.

Official Title
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Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial

Conditions
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Atrial Fibrillation, Catheter Ablation

Intervention / Treatment
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* Drug: Protamine Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial). Age ≥ 18 year Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial. Exclusion Criteria: Previous intolerance or allergy to heparin products. Current or prior administration of protamine products History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm. Known lower extremity venous thrombosis. Coagulopathy or blood dyscrasias. Active malignancy. Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul) Planned use of vascular closure device

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in the control arm will undergo routine post-procedure management prior to removal of vascular sheaths. This includes routine measurements of ACT beginning 90 min after the cessation of the procedure with a goal ACT of <200s or return to pre-procedural baseline prior to sheath removal. | |
| Active Comparator: Protamine<br>Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs.ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths. | Drug: Protamine Sulfate<br>* Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation | Total length of time from procedural termination to patient ambulation | 0 to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Participants Who Experienced Vascular Access Site Complications | Secondary endpoints will include the number of patients who experience a 90-day occurrence of vascular access site complications defined as hematoma formation, aneurysm, pseudoaneurysm, arteriovenous fistula formation, access-site related major bleeding (defined as Bleeding Academic Research Consortium (BARC) type 3a or 5), or procedural intervention for access complications (surgical repair, thrombin injection, et cetera) | checked at 30 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation, atrial fibrillation, protamine sulfate, anticoagulation reversal