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OpenTrials
Completed

NCT Number: NCT03040661

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ablation for atrial fibrillation.

Procedure

Ablation for atrial fibrillation.

Primary outcomes

  1. Time Required to Achieve Hemostasis

    Time frame: Time (minutes) from sheath removal till hemostasis achieved

    Time Required to Achieve Hemostasis (minutes)

  2. Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

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

Acronym: Figure 8

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2017
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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