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

Atrial Fibrillation Clinical Trial

— Figure 8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040661
• Other study ID #: 16-2381
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: December 2021
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablation for atrial fibrillation.
Ablation for atrial fibrillation.

Locations

Country	Name	City	State
United States	Inova Fairfax Hospital	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Required to Achieve Hemostasis	Time Required to Achieve Hemostasis (minutes)	Time (minutes) from sheath removal till hemostasis achieved
Primary	Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.	Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)	Time (minutes) from completion of procedure till patient leaves room
Secondary	Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group	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.	Assessed after sheath removal till patient discharge