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Comparison of Percutaneous Closure to Manual Compression for Hemostasis

NCT04180540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2022-02-07

Study results available
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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.

Conditions

Interventions

DEVICE

Percutaneous Closure

The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.

OTHER

Manual Compression

Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without "figure of eight" suture for hemostasis at the discretion of the treating physician).

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Michael S. Lloyd

    lead OTHER

Principal Investigators

  • Michael Lloyd, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2021-01-13
Completion
2021-01-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180540 on ClinicalTrials.gov