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Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures.
Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.
This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC (Aurora St. Luke's Medical Center):
Large-Bore Procedures >13 F
RANDOMIZATION:
Patients will be randomized into one of two venous closure groups after a clean stick has been achieved with no complications:
Large-bore (14F-25F) venous access group (1:1)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Experimental | Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F. |
|
| Figure 8 Suture - LARGE-BORE PROCEDURES | Active Comparator | Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Device | The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Hemostasis | The elapsed time between "device" removal and first observed and confirmed venous hemostasis | Day 1 |
| Time to Ambulate | The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge (TTD)/Length of Stay (LOS) | The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay. | up to 5 days post procedure |
| Post Procedure Major Bleeding |
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Inclusion criteria:
Large-bore (>13F) Venous Access Procedures Inclusion Criteria:
All patients 18 years and older who are undergoing any of the following: WATCHMAN® device placement, atrial fibrillation ablation using cryoballoon or laser balloon, leadless pacemaker, Pulmonary embolism thrombectomy (Inari FlowTriever system), MitraClip transcatheter mitral valve repair at Aurora St. Luke's Medical Center from date of IRB (Institutional Review Board) approval through December 2022. All arterial line access should be radial.
Exclusion criteria:
Large-bore (>13F) Venous Access Procedures Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad E Mortada, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39087741 | Derived | Ali M, Masood F, Erickson L, Adefisoye J, Kanani J, Walczak S, Ajam T, Kieu A, Premjee M, Jan MF, Allaqaband SQ, Bajwa T, Khitha J, Zilinski J, Jahangir A, Djelmami-Hani M, Sra J, Niazi I, Mortada ME. Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device. Catheter Cardiovasc Interv. 2024 Oct;104(4):820-828. doi: 10.1002/ccd.31173. Epub 2024 Aug 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F. Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 1, 2022 |
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| Figure 8 Suture - LARGE-BORE PROCEDURES | Other | A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures. |
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Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.
| up to 30 days post procedure |
| Minor Bleeding | Any bleeding that does not meet the criteria for major bleeding | up to 30 days post procedure |
| Access Site Complications | Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula | up to 30 days post procedure |
| Mortality | Mortality due to vascular complications | up to 30 days post procedure |
| FG001 | Figure 8 Suture - LARGE-BORE PROCEDURES | Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F. Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F. Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis. |
| BG001 | Figure 8 Suture - LARGE-BORE PROCEDURES | Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F. Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | Kg/m2 |
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| Diabetes Mellitus | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Chronic kidney disease/hemodialysis | Count of Participants | Participants |
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| End stage liver disease | Count of Participants | Participants |
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| Prior stroke or trans ischemic attack | Count of Participants | Participants |
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| 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 to Achieve Hemostasis | The elapsed time between "device" removal and first observed and confirmed venous hemostasis | Posted | Median | Inter-Quartile Range | Minutes | Day 1 |
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| Primary | Time to Ambulate | The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites. | Posted | Median | Inter-Quartile Range | Minutes | Day 1 |
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| Secondary | Time to Discharge (TTD)/Length of Stay (LOS) | The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay. | Posted | Median | Inter-Quartile Range | Minutes | up to 5 days post procedure |
|
| ||||||||||||||||||||||||||||||
| Secondary | Post Procedure Major Bleeding | Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death. | Posted | Count of Participants | Participants | up to 30 days post procedure |
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| Secondary | Minor Bleeding | Any bleeding that does not meet the criteria for major bleeding | Posted | Count of Participants | Participants | up to 30 days post procedure |
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| Secondary | Access Site Complications | Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula | Posted | Count of Participants | Participants | up to 30 days post procedure |
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| Secondary | Mortality | Mortality due to vascular complications | Posted | Count of Participants | Participants | up to 30 days post procedure |
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Within 30 days of procedure date
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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 | Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F. Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES: The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis. | 0 | 47 | 5 | 47 | 9 | 47 |
| EG001 | Figure 8 Suture - LARGE-BORE PROCEDURES | Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F. Figure 8 Suture - LARGE-BORE PROCEDURES: A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures. | 0 | 53 | 5 | 53 | 5 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI bleed | Gastrointestinal disorders | Non-systematic Assessment | Unexpected, unrelated to study |
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| Severe mitral valve regurgitation | Cardiac disorders | Non-systematic Assessment | Unexpected, unrelated to study |
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| Stroke | Vascular disorders | Non-systematic Assessment | Unexpected, unrelated to study |
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| Bleeding and Hematoma | Surgical and medical procedures | Non-systematic Assessment | Expected risk, unrelated to the study |
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| Acute anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Unexpected, unrelated to study |
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| Oozing | Injury, poisoning and procedural complications | Non-systematic Assessment | Expected risk, possibly related to the closure method |
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| Bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment | Expected risk, possibly related to the closure method |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment | Expected risk, possibly related to study |
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| Bilateral groin bruising/ecchymosis | Injury, poisoning and procedural complications | Non-systematic Assessment | Expected risk, unlikely related to study |
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| Oozing | Injury, poisoning and procedural complications | Non-systematic Assessment | Expected risk, possibly related to study |
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| Bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment | Expected risk, possibly related to study |
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| Hematuria | Renal and urinary disorders | Non-systematic Assessment | Unexpected risk, unrelated to study |
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| Wrist/forearm pain/swelling and bruising | Injury, poisoning and procedural complications | Non-systematic Assessment | Unexpected risk, unrelated to study |
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| Atypical chest pain | Cardiac disorders | Non-systematic Assessment | Unexpected risk, unrelated to study |
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| Chest pain | Infections and infestations | Non-systematic Assessment | Unexpected risk, unrelated to study |
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| Severe headache and hypertension | General disorders | Non-systematic Assessment | Unexpected risk, unrelated to study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mahmoud Ali | Aurora Health Care | (262) 948-6630 | mahmoud.ali@aah.org |
| Feb 15, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D006327 | Heart Block |
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| D012804 | Sick Sinus Syndrome |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D001146 | Arrhythmia, Sinus |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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