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This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.
This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Device | Experimental | A single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis. |
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| Two device | Active Comparator | Two Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Perclose Pro vascular closure device | Device | Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Vascular Complications | Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization. | Day 5 post-procedure |
| Number of Patients With Life-threatening bleeding | Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure. | Hour 24 post-procedure |
| Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition | Number of subjects in each group experiencing bleeding complications related to the TAVR procedure that do not meet the criteria for life-threatening bleeding but still result in significant clinical concern within 24 hours of the index procedure. | Hour 24 post-procedure |
| Time to Hemostasis | For each subject, time elapsed from initial deployment of the initial one or two Perclose devices (depending on assigned group) to complete hemostasis of the femoral access site. Measured in seconds. | 1 hour post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Closure Device Use | Number of subjects requiring use of additional closure devices beyond the initial closure strategy required to achieve hemostasis at the femoral access site within 24 hours post-procedure. The number and type of devices will be recorded for each subject. | Hour 24 post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suhail Q Allaqaband, MD | Contact | 414-649-3491 | suhail.allaqaband@aah.org |
| Name | Affiliation | Role |
|---|---|---|
| Suhail Q Allaqaband, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora St. Luke's Medical Center | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Dual Perclose vascular closure device | Device | Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath. |
|
| In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions |
Number of subjects in each group experiencing severe vascular complications that necessitate either percutaneous procedures or surgical interventions during the index hospitalization. |
| Day 5 post-procedure |
| Number of Patients With Limb Ischemia Related to TAVR During Index Admission | Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure between the TAVR procedure and discharge. | Day 5 post-procedure |
| Limb Ischemia Related to TAVR | Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure monitored within 30 days post procedure. | Day 30 post-procedure |