Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04180540 |
| Other study ID # |
IRB00115958 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 22, 2020 |
| Est. completion date |
January 13, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Emory University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 (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.
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.
