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Atrial FibrillationNCT04180540

Comparison of Percutaneous Closure to Manual Compression for Hemostasis

A study testing Percutaneous Closure and Manual Compression in people with Atrial Fibrillation, run by Michael S. Lloyd at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Percutaneous Closure and Manual Compression
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
2 sitesUnited States
Study dates
22 Jan 2020to 13 Jan 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • undergoing elective atrial fibrillation ablation at Emory University Hospital or Emory University Hospital Midtown

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory Clinic, Emory University Hospital

    Atlanta, Georgia, 30322

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Percutaneous Closure, Manual Compression
Keywords
Cardiology, Electrophysiology
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous ClosureDevice

    Also called PerClose Proglide

    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.

  • 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).

Study groups in NCT04180540
Study groupRoleWhat they receive
Percutaneous ClosureExperimentalParticipants randomized to undergo percutaneous closure with PerClose after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Receives: Device: Percutaneous Closure
Manual CompressionActive comparatorParticipants randomized to undergo manual compression after radiofrequency ablation or cryoablation for treatment of atrial fibrillation.
Receives: Other: Manual Compression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Hemostasis

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

    Measured: Day 1

Secondary outcomes (8)

  1. Time to Ambulation

    Time to ambulation (in minutes) following the atrial fibrillation ablation, will be compared between study arms.

    Measured: Day 1

  2. Number of Complications

    Number of complications will be compared between study arms as a composite of all major access site complications and venous thromboembolism.

    Measured: Day 30

  3. Short-form Inguinal Pain Questionnaire Score

    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. The questionnaire consists of two items, each with a score ranging from 0 to 6. Question 1 asks participants to report the worst pain they have experienced in the past week, where responses range from 0 (no pain) to 6 (pain present, prompt medical advice sought). If participants have experienced pain, Question 2 asks what limitations the pain has caused in performing everyday activities such as sitting down, standing up, or exercising. The total score for question 2 ranges from 0 (none of the listed activities were impacted) to 6 (all listed activities were impacted).

    Measured: Day 30

  4. Procedure Length

    The length of the procedure to reach hemostasis, in minutes, will be compared between study arms.

    Measured: Day 1

  5. Patient Satisfaction

    Patient satisfaction was assessed with a 6-item instrument where participants responded on a scale from 0 to 5 where 0 = completely satisfied and 5 = completely dissatisfied. The sum of scores can range from 0 to 30 and lower scores indicate greater satisfaction with pain level and appearance of the access site. Measurements were taken at discharge (day 1) and the same instrument was used on follow up (day 30).

    Measured: Day 1 and Day 30

  6. Pain Medication Needs

    Post-procedure narcotic usage for pain medication requirements after hemostasis until discharge from the post-procedure area will be compared between study arms.

    Measured: Day 1

  7. Costs

    Overall costs (in dollars) related to hemostasis and any complications over 30 days will be compared between study arms.

    Measured: Day 30

  8. Number of Nursing Encounters

    The number of nursing encounters while in the post-procedure area will be compared between study arms.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start22 Jan 2020
  3. Primary completion13 Jan 2021
  4. Study completion13 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04180540
Sponsor's protocol ID
IRB00115958
Status last verified
Jan 2022
First submitted
26 Nov 2019
Last updated
7 Feb 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kiani S, Eggebeen J, Al-Gibbawi M, Smith P, Preiser T, Kundu S, Zheng Z, Bhatia NK, Shah AD, Westerman SB, De Lurgio DB, Tompkins CM, Patel AM, El-Chami MF, Merchant FM, Lloyd MS. Costs, efficiency, and patient-reported outcomes associated with suture-mediated percutaneous closure for atrial fibrillation ablation: Secondary analysis of a randomized clinical trial. J Cardiovasc Electrophysiol. 2024 Dec;35(12):2372-2381. doi: 10.1111/jce.16440. Epub 2024 Oct 8.

    PubMed 39377569

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Closure and Manual Compression in people with Atrial Fibrillation, run by Michael S. Lloyd at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Hemostasis (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04180540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.

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