Comparison of Percutaneous Closure to Manual Compression for Hemostasis

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

This a prospective randomized trial occurring in patients undergoing routine ablation for atrial fibrillation as standard of care. The purpose of this study is to determine if using a small internal suture (or "stitch") facilitates faster times to hemostasis (stopping bleeding) after removing intravenous sheaths (special IVs that are used for ablation procedures) after an atrial fibrillation ablation procedure. The device used to place the stitch is PerClose Proglide and is an already FDA-approved technology for closing these IV sites. The study will also determine if it is safe to get up and walk sooner than what is considered typical after closing these IV sites with the PerClose device. Participants will be randomized in a 1:1 ratio to either manual compression or use of the PerClose for hemostasis at the end of the ablation procedure. The length of follow-up will be up to 30 days at routine clinical follow-up after the procedure.

Key facts

Study ID: NCT04180540
Run by: Michael S. Lloyd
People needed: 109
Starts: 2020-01-22
Expected to finish: 2021-01-13
Last updated by the study team: 2022-02-07

Who can join

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

You may qualify if…

undergoing elective atrial fibrillation ablation at Emory University Hospital or Emory University Hospital Midtown

You may not qualify if…

women who are pregnant (based on standard pre-procedure pregnancy test)
patients who are not able to ambulate pre-procedure
patients who are unable to provide informed consent

Where it is running

Emory University Hospital Midtown — Atlanta, Georgia, United States
Emory Clinic, Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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