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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040661
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Inova Health Care Services

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Ablation for atrial fibrillation. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Figure of 8 Suture
Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.
Procedure: Ablation for atrial fibrillation.
Ablation for atrial fibrillation.

Active Comparator: Manual Hemostasis Group
Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.
Procedure: Ablation for atrial fibrillation.
Ablation for atrial fibrillation.




Primary Outcome Measures :
  1. Time Required to Achieve Hemostasis [ Time Frame: 2 hours ]
  2. Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab. [ Time Frame: 2hours ]

Secondary Outcome Measures :
  1. Groin complications including bleeds, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion [ Time Frame: 1 Month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040661


Locations
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United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03040661    
Other Study ID Numbers: 16-2381
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes