Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Atrial Fibrillation, Catheter Ablation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, protamine sulfate, anticoagulation reversal
Eligibility Criteria
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
Sites / Locations
- Michigan Medicine
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
Control
Protamine
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.
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.