Phase 4
N=150
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Atrial Fibrillation · Catheter Ablation
Bottom Line
View on ClinicalTrials.gov: NCT03140631 ↗Enrolled (actual)
150
Serious AEs
1.3%
Results posted
Oct 2018
Primary outcome: Primary: Time to Ambulation — 480; 316 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Protamine Sulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Ambulation |
480; 316 | <0.001 sig |
| SECONDARY Count of Participants Who Experienced Vascular Access Site Complications |
4; 6; 4; 6 | 0.74 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03140631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.