At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 153 enrolled
Drug / intervention
Protamine Sulfatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial
In Brief
A Phase 4 clinical trial evaluating Protamine Sulfate for Atrial Fibrillation and Catheter Ablation. Completed, enrolled 153 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Catheter Ablation
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedMay 2017
Primary CompletionNov 2017
Study CompletionApr 2018
TodayJul 2026
First PostedMay 4, 2017
Enrollment StartMar 23, 2017
Primary CompletionNov 16, 2017
Study CompletionApr 3, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.2 years ago
Interventions
Protamine Sulfatedrug
Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.