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

• Status: Completed
• Trial end date: 2018-04-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Calcium heparin; Heparin; Protamines

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