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

Completed · Phase 4

Conditions studied: Atrial Fibrillation, Catheter Ablation

In brief

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.

Key facts

Study ID

NCT03140631

Run by

University of Michigan

People needed

153

Starts

2017-03-23

Expected to finish

2018-04-03

Last updated by the study team

2018-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Michigan Medicine — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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