Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Florida Atlantic University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.
Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Figure-of-eight | Active Comparator | Using the figure-of-eight closure technique when closing access for structural heart therapies. |
|
| Perclose Device | Active Comparator | Using the Perclose device when closing access for structural heart therapies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Figure-of-eight suture | Other | Using the figure-of-eight closure technique when closing access for structural heart therapies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis Time | To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access | Immediate |
| Procedure Time | Immediate | |
| Access Site Complication | 1 month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Houman Khalili, MD | Delray Medical Center | Principal Investigator |
| Brijeshwar Maini | Delray Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delray Medical Center | Delray Beach | Florida | 33484 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Perclose Device | Other | Using the Perclose device when closing access for structural heart therapies. |
|