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

NCT ID: NCT03040661

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-06-01

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).

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

Figure of 8 Suture

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

Group Type: EXPERIMENTAL

Ablation for atrial fibrillation.

Intervention Type: PROCEDURE

Ablation for atrial fibrillation.

Manual Hemostasis Group

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

Group Type: ACTIVE_COMPARATOR

Ablation for atrial fibrillation.

Intervention Type: PROCEDURE

Ablation for atrial fibrillation.

Interventions

Ablation for atrial fibrillation.

Ablation for atrial fibrillation.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

Sponsors

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inova Fairfax Hospital

Falls Church, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-2381

Identifier Type: -

Identifier Source: org_study_id