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Completed

NCT Number: NCT03140631

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protamine sulfate

Drug

Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.

Primary outcomes

  1. Time to Ambulation

    Time frame: 0 to 24 hours

    Total length of time from procedural termination to patient ambulation

Secondary outcomes

  1. Count of Participants Who Experienced Vascular Access Site Complications

    Time frame: checked at 30 and 90 days

    Secondary endpoints will include the number of patients who experience a 90-day occurrence of vascular access site complications defined as hematoma formation, aneurysm, pseudoaneurysm, arteriovenous fistula formation, access-site related major bleeding (defined as Bleeding Academic Research Consortium (BARC) type 3a or 5), or procedural intervention for access complications (surgical repair, thrombin injection, et cetera)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 4, 2017
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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