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

NCT03040661 | Completed Results

• 1 other identifier: 16-2381
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Time Required to Achieve Hemostasis

  Time Required to Achieve Hemostasis (minutes)

  Time (minutes) from sheath removal till hemostasis achieved

• 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 Outcomes (1)

• Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group

  Assessed after sheath removal till patient discharge

Study Arms (2)

Figure of 8 Suture

EXPERIMENTAL

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

Procedure: Ablation for atrial fibrillation.

Manual Hemostasis Group

ACTIVE COMPARATOR

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

Procedure: Ablation for atrial fibrillation.

Interventions

Ablation for atrial fibrillation. PROCEDURE

Ablation for atrial fibrillation.

Figure of 8 Suture; Manual Hemostasis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant patients.
• Age \<18 years.
• Patients who cannot provide consent in English.
• Prisoners.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vineet Kumar
• Organization: Inova Heart and Vascular Institute

vineet.kumar@inova.org

(703) 289-9400

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 2, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Locations

US (1)