Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture (Figure 8)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ablation for atrial fibrillation.
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
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.
- Prisoners.
Sites / Locations
- Inova Fairfax Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Figure of 8 Suture
Manual Hemostasis Group
Arm Description
Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.
Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.
Outcomes
Primary Outcome Measures
Time Required to Achieve Hemostasis
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 required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03040661
First Posted
January 24, 2017
Last Updated
December 23, 2021
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT03040661
Brief Title
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Acronym
Figure 8
Official Title
Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Figure of 8 Suture
Arm Type
Experimental
Arm Description
Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.
Arm Title
Manual Hemostasis Group
Arm Type
Active Comparator
Arm Description
Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.
Intervention Type
Procedure
Intervention Name(s)
Ablation for atrial fibrillation.
Intervention Description
Ablation for atrial fibrillation.
Primary Outcome Measure Information:
Title
Time Required to Achieve Hemostasis
Description
Time Required to Achieve Hemostasis (minutes)
Time Frame
Time (minutes) from sheath removal till hemostasis achieved
Title
Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.
Description
Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)
Time Frame
Time (minutes) from completion of procedure till patient leaves room
Secondary Outcome Measure Information:
Title
Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group
Description
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.
Time Frame
Assessed after sheath removal till patient discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Prisoners.
Facility Information:
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture
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