NCT04180540

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 7, 2022

Completed
Last Updated

February 7, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

November 26, 2019

Results QC Date

November 15, 2021

Last Update Submit

January 7, 2022

Conditions

Atrial Fibrillation

Keywords

CardiologyElectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Time to Hemostasis

    Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms.

    Day 1

Secondary Outcomes (8)

  • Time to Ambulation

    Day 1

  • Number of Complications

    Day 30

  • Short-form Inguinal Pain Questionnaire Score

    Day 30

  • Procedure Length

    Day 1

  • Patient Satisfaction

    Day 1 and Day 30

  • +3 more secondary outcomes

Study Arms (2)

Percutaneous Closure

EXPERIMENTAL

Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.

Device: Percutaneous Closure

Manual Compression

ACTIVE COMPARATOR

Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.

Other: Manual Compression

Interventions

Percutaneous ClosureDEVICE

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.

Also known as: PerClose Proglide
Percutaneous Closure
Manual CompressionOTHER

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).

Manual Compression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Clinic, Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Michael lloyd
Organization
Emory University
mlloyd@emory.edu
404-712-4063

Study Officials

  • Michael Lloyd, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 27, 2019

Study Start

January 22, 2020

Primary Completion

January 13, 2021

Study Completion

January 13, 2021

Last Updated

February 7, 2022

Results First Posted

February 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)