Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Ablation for atrial fibrillation.

• Registration Number: NCT03040661
• Lead Sponsor: Inova Health Care Services

Brief Summary

Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the procedure, heparin is administered to maintain a target ACT \> 300 seconds. At the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach, an ACT is checked and protamine is administered. The ACT is rechecked 20" later, and if \< 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Study Start: 2017-03-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-06-01
• Results First Submitted: 2019-12-06
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-23
• Last Update Submitted: 2021-12-23
• Results First Posted: 2022-01-11
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Any patient who meets standard clinical criteria for an ablation of AF with Cryoballoon, and is to undergo the procedure

Exclusion Criteria

1. Pregnant patients.
2. Age <18 years.
3. Patients who cannot provide consent in English.
4. Prisoners.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Hemostasis Group	Ablation for atrial fibrillation.	Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.
Figure of 8 Suture	Ablation for atrial fibrillation.	Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.

Primary Outcome Measures

Name	Time	Method
Time Required to Achieve Hemostasis	Time (minutes) from sheath removal till hemostasis achieved	Time Required to Achieve Hemostasis (minutes)
Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.	Time (minutes) from completion of procedure till patient leaves room	Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)

Secondary Outcome Measures

Name	Time	Method
Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group	Assessed after sheath removal till patient discharge	Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.

Trial Locations

Locations (1)

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States