Clinical trial NCT04180540: Comparison of Percutaneous Closure to Manual Compression for Hemostasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Cardiology
Electrophysiology
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2019-11-27
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Time to Hemostasis
timeFrame: Day 1
Secondary outcomes:
measure: Time to Ambulation
timeFrame: Day 1
measure: Number of Complications
timeFrame: Day 30
measure: Short-form Inguinal Pain Questionnaire Score
timeFrame: Day 30
measure: Procedure Length
timeFrame: Day 1
measure: Patient Satisfaction
timeFrame: Day 1 and Day 30
measure: Pain Medication Needs
timeFrame: Day 1
measure: Costs
timeFrame: Day 30
measure: Number of Nursing Encounters
timeFrame: Day 1
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic, Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Michael Lloyd, MD
role: PRINCIPAL_INVESTIGATOR
References: