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Comparison of Percutaneous Closure to Manual Compression for Hemostasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180540
Recruitment Status : Enrolling by invitation
First Posted : November 27, 2019
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Michael S. Lloyd, Emory University

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Percutaneous Closure Other: Manual Compression Not Applicable

Detailed Description:
Radiofrequency ablation and cryoablation for treatment of atrial fibrillation (AF) using percutaneous venous access at the groin is one of the most common procedures performed by cardiac electrophysiologists. However, compared to other catheter-based interventions, patients undergoing AF ablation pose a unique set of challenges. First, AF ablation requires multiple points of transfemoral venous access with large diameter sheaths, ranging in size from 8 French gauge (F) to 14F for cryoablation procedures. Second, operators are forced to balance the competing risk of thrombosis and bleeding in these patients. In order to minimize the risk of intraprocedural thrombosis, anticoagulation with heparin with a goal anticoagulation time (ACT) >300-350 seconds is necessary. However, operators typically require ACTs to normalize prior to removal of sheaths and manual compression, which significantly delays hemostasis and ambulation. While reversal agents are an option, there is currently clinical equipoise on their role and safety in this setting and they require additional time to exert their full effect. Lastly, patients require at least 1-2 months of therapeutic oral anticoagulation after the procedure to mitigate ongoing stroke risk. These factors culminate in longer times to hemostasis and ambulation and raise concerns for post-procedure access related complications for patients undergoing AF ablation. PerClose Proglide has recently gained FDA approval for closure of percutaneous venous access sites for catheter-based interventions and remains the only commercially available solution for access sites >14F inner diameter. Percutaneous closure of venotomy sites may facilitate rapid hemostasis without the need for reversal of anticoagulation, potentially attenuating bleeding risk. Additionally, typical bedrest times after percutaneous closure are based on data derived from arterial closure. Prior limited data, as well as frequent anecdotal reports, have suggested that earlier ambulation may be feasible. Because the venous circulation is a lower pressure system, it is possible that earlier than standard ambulation times after PerClose is both safe and feasible. However, a rigorous prospective investigation of the PerClose Proglide device in the context of AF ablation has not been performed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Comparison of Percutaneous Closure to Manual Compression for Hemostasis of Multiple Venous Access Sites Among Patients Undergoing Catheter Ablation for Atrial Fibrillation
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Percutaneous Closure
Participants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
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 Name: PerClose Proglide

Active Comparator: Manual Compression
Participants randomized to undergo manual compression after radiofrequency ablation or cryoablation 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).




Primary Outcome Measures :
  1. Time to Hemostasis [ Time Frame: Day 1 ]
    Starting from sheath pull, time (in minutes) to hemostasis will be compared between study arms.


Secondary Outcome Measures :
  1. Time to Ambulation [ Time Frame: Day 1 ]
    Time to ambulation (in minutes) following the atrial fibrillation ablation, will be compared between study arms.

  2. Number of Complications [ Time Frame: Day 30 ]
    Number of complications will be compared between study arms as a composite of all major access site complications and venous thromboembolism.

  3. Short-form Inguinal Pain Questionnaire Score [ Time Frame: Day 30 ]
    The Short-form Inguinal Pain Questionnaire is a quality of life metric where respondents report how much pain they have experienced in the past week and how pain has limited their activities. Total scores for this 2-item questionnaire ranges from 0 to 12 where higher scores indicate greater pain.

  4. Procedure Length [ Time Frame: Day 1 ]
    The length of the procedure to reach hemostasis, in minutes, will be compared between study arms.

  5. Patient Satisfaction [ Time Frame: Day 1 and Day 30 ]
    Patient satisfaction with groin access site will be assessed with a 6-item instrument where participants respond on a scale from 0 to 5 where 0 = completely satisfied and 5 = completely dissatisfied. Total scores range from 0 to 30 and lower scores indicate greater satisfaction with pain level and appearance of the access site.

  6. Pain Medication Needs [ Time Frame: Day 1 ]
    Post-procedure narcotic usage for pain medication requirements after hemostasis until discharge from the post-procedure area will be compared between study arms.

  7. Costs [ Time Frame: Day 30 ]
    Overall costs (in dollars) related to hemostasis and any complications over 30 days will be compared between study arms.

  8. Number of Nursing Encounters [ Time Frame: Day 1 ]
    The number of nursing encounters while in the post-procedure area will be compared between study arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180540


Locations
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United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory Clinic, Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Michael S. Lloyd
Abbott
Investigators
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Principal Investigator: Michael Lloyd, MD Emory University
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Responsible Party: Michael S. Lloyd, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT04180540    
Other Study ID Numbers: IRB00115958
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Michael S. Lloyd, Emory University:
Cardiology
Electrophysiology
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes