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

Inova Health Care Services

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Ablation for atrial fibrillation.

Study type: Interventional

Funder types: Other

Identifiers

NCT03040661

16-2381

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Figure of 8 Suture

Experimental group

Description:

Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.

Treatment:

Procedure: Ablation for atrial fibrillation.

Manual Hemostasis Group

Active Comparator group

Description:

Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.

Treatment:

Procedure: Ablation for atrial fibrillation.