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Clinical Trials/NCT03040661
NCT03040661
Completed
Not Applicable

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

Inova Health Care Services1 site in 1 country70 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Inova Health Care Services
Enrollment
70
Locations
1
Primary Endpoint
Time Required to Achieve Hemostasis
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
June 1, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

Time Required to Achieve Hemostasis

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

Time Required to Achieve Hemostasis (minutes)

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

  • Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group(Assessed after sheath removal till patient discharge)

Study Sites (1)

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