N/A
Completed N=109
Comparison of Percutaneous Closure to Manual Compression for Hemostasis
Source: ClinicalTrials.gov NCT04180540 ↗Enrolled (actual)
109
Serious AEs
2.8%
Results posted
Feb 2022
Primary outcomePrimary: Time to Hemostasis — 4.5; 10.7 seconds
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis |
4.5; 10.7 | — |
| SECONDARY Time to Ambulation |
1.33; 2.25 | — |
| SECONDARY Number of Complications |
0; 1; 0; 1 | — |
| SECONDARY Short-form Inguinal Pain Questionnaire Score |
0; 0; 0; 0 | — |
| SECONDARY Procedure Length |
158.06; 156.83; 141.81; 146.15 | — |
| SECONDARY Patient Satisfaction |
1.13; 0.72; 0.59; 0.25; 1.21; 0.65 | — |
| SECONDARY Pain Medication Needs |
8; 5 | — |
| SECONDARY Costs |
882; 4; 882; 42; 57,050.44; 56,533.65 | — |
| SECONDARY Number of Nursing Encounters |
0.06; 0.09 | — |
Eligibility Criteria
Inclusion Criteria
- undergoing elective atrial fibrillation ablation at Emory University Hospital or Emory University Hospital Midtown
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04180540). 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. Informational only — not medical advice.