Atrial Fibrillation
Conditions
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).
Interventions
PROCEDUREAblation for atrial fibrillation.
Ablation for atrial fibrillation.
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Required to Achieve Hemostasis | 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 (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
| Measure | Time frame | Description |
|---|---|---|
| Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Figure of 8 Suture Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.
Ablation for atrial fibrillation.: Ablation for atrial fibrillation. | 35 |
| Manual Hemostasis Group Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.
Ablation for atrial fibrillation.: Ablation for atrial fibrillation. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Figure of 8 Suture | Total | Manual Hemostasis Group |
|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 9.5 | 62.1 years STANDARD_DEVIATION 9.5 | 62.1 years STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 61 Participants | 31 Participants |
| Region of Enrollment United States | 35 participants | 70 participants | 35 participants |
| Sex: Female, Male Female | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 21 Participants | 43 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 2 / 35 | 2 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
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 frame: Time (minutes) from completion of procedure till patient leaves room
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Figure of 8 Suture | Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab. | 20 minutes | Standard Deviation 5 |
| Manual Hemostasis Group | Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab. | 28 minutes | Standard Deviation 9 |
Primary
Time Required to Achieve Hemostasis
Time Required to Achieve Hemostasis (minutes)
Time frame: Time (minutes) from sheath removal till hemostasis achieved
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Figure of 8 Suture | Time Required to Achieve Hemostasis | 0 minutes | Standard Deviation 0 |
| Manual Hemostasis Group | Time Required to Achieve Hemostasis | 15 minutes | Standard Deviation 6 |
Secondary
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.
Time frame: Assessed after sheath removal till patient discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Figure of 8 Suture | Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group | 8.6 percent |
| Manual Hemostasis Group | Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group | 34.2 percent |