Comparison of Percutaneous Closure to Manual Compression for Hemostasis

NCT ID: NCT04180540

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2021-01-13

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.

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Percutaneous Closure

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

Group Type: EXPERIMENTAL

Percutaneous Closure

Intervention Type: DEVICE

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 Compression

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

Group Type: ACTIVE_COMPARATOR

Manual Compression

Intervention Type: OTHER

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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: OTHER

Other Intervention Names

PerClose Proglide

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Michael S. Lloyd

OTHER

Sponsor Role: lead

Responsible Party

Michael S. Lloyd

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Lloyd, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory Clinic, Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00115958

Identifier Type: -

Identifier Source: org_study_id