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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Figure of 8 Suture | Experimental | Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. |
|
| Manual Hemostasis Group | Active Comparator | Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation for atrial fibrillation. | Procedure | Ablation for atrial fibrillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Required to Achieve Hemostasis | Time Required to Achieve Hemostasis (minutes) | Time (minutes) from sheath removal till hemostasis achieved |
| 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 (minutes) from completion of procedure till patient leaves room |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed after sheath removal till patient discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Manual Hemostasis Group | Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation.: Ablation for atrial fibrillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Manual Hemostasis Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Required to Achieve Hemostasis | Time Required to Achieve Hemostasis (minutes) | Posted | Mean | Standard Deviation | minutes | Time (minutes) from sheath removal till hemostasis achieved |
|
In-hospital and 30 days post procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Figure of 8 Suture | Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture. Ablation for atrial fibrillation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma or minor bleeding at site | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vineet Kumar | Inova Heart and Vascular Institute | (703) 289-9400 | vineet.kumar@inova.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2016 | Dec 31, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.
Ablation for atrial fibrillation.: Ablation for atrial fibrillation.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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) | Posted | Mean | Standard Deviation | minutes | Time (minutes) from completion of procedure till patient leaves room |
|
|
|
| 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. | Posted | Number | percent | Assessed after sheath removal till patient discharge |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | Manual Hemostasis Group | Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique. Ablation for atrial fibrillation | 0 | 35 | 0 | 35 | 2 | 35 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |