N/A N=109 Randomized Supportive Care

Comparison of Percutaneous Closure to Manual Compression for Hemostasis

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT04180540 ↗

Enrolled (actual)

109

Serious AEs

2.8%

Results posted

Feb 2022

Primary outcome: Primary: Time to Hemostasis — 4.5; 10.7 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Percutaneous Closure (Device); Manual Compression (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Michael S. Lloyd
Primary completion: Jan 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

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.