Atrial Fibrillation, Atrial Flutter, Bradycardia, Brady-tachy Syndrome, Heart Block, Mitral Valve Repair, Pulmonary Embolism and Thrombosis, Sinus Node Dysfunction
Conditions
Brief summary
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.
Detailed description
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 1. WATCHMAN® device placement 2. Atrial fibrillation/flutter/SVT (supraventricular tachycardia) ablation using cryoballoon or laser balloon 3. Leadless pacemaker 4. Pulmonary embolism thrombectomy (Inari FlowTriever system) 5. MitraClip transcatheter mitral valve repair 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) * Perclose ProGlide SMC * Figure 8 suture
Interventions
DEVICEPerclose 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.
OTHERFigure 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Hemostasis | Day 1 | The elapsed time between device removal and first observed and confirmed venous hemostasis |
| Time to Ambulate | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minor Bleeding | up to 30 days post procedure | Any bleeding that does not meet the criteria for major bleeding |
| Time to Discharge (TTD)/Length of Stay (LOS) | up to 5 days post procedure | The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay. |
| Mortality | up to 30 days post procedure | Mortality due to vascular complications |
| Access Site Complications | up to 30 days post procedure | Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula |
| Post Procedure Major Bleeding | up to 30 days post procedure | Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 53 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Figure 8 Suture - LARGE-BORE PROCEDURES | Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES |
|---|---|---|---|
| Age, Continuous | 69.6 Years STANDARD_DEVIATION 11 | 69.6 Years STANDARD_DEVIATION 11.7 | 69.5 Years STANDARD_DEVIATION 10.3 |
| Body Mass Index | 31.0 Kg/m2 STANDARD_DEVIATION 6.9 | 30.3 Kg/m2 STANDARD_DEVIATION 6.6 | 31.8 Kg/m2 STANDARD_DEVIATION 7.1 |
| Chronic kidney disease/hemodialysis | 9 Participants | 6 Participants | 3 Participants |
| Diabetes Mellitus | 21 Participants | 11 Participants | 10 Participants |
| End stage liver disease | 2 Participants | 0 Participants | 2 Participants |
| Hypertension | 58 Participants | 31 Participants | 27 Participants |
| Prior stroke or trans ischemic attack | 13 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 99 Participants | 53 Participants | 46 Participants |
| Sex: Female, Male Female | 37 Participants | 17 Participants | 20 Participants |
| Sex: Female, Male Male | 63 Participants | 36 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 53 |
| other Total, other adverse events | 9 / 47 | 5 / 53 |
| serious Total, serious adverse events | 5 / 47 | 5 / 53 |
Outcome results
Primary
Time to Achieve Hemostasis
The elapsed time between device removal and first observed and confirmed venous hemostasis
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Time to Achieve Hemostasis | 7 Minutes |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Time to Achieve Hemostasis | 11 Minutes |
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.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Time to Ambulate | 322 Minutes |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Time to Ambulate | 403 Minutes |
Secondary
Access Site Complications
Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula
Time frame: up to 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Access Site Complications | 0 Participants |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Access Site Complications | 2 Participants |
Secondary
Minor Bleeding
Any bleeding that does not meet the criteria for major bleeding
Time frame: up to 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Minor Bleeding | 5 Participants |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Minor Bleeding | 4 Participants |
Secondary
Mortality
Mortality due to vascular complications
Time frame: up to 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Mortality | 0 Participants |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Mortality | 0 Participants |
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.
Time frame: up to 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Post Procedure Major Bleeding | 0 Participants |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Post Procedure Major Bleeding | 0 Participants |
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.
Time frame: up to 5 days post procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES | Time to Discharge (TTD)/Length of Stay (LOS) | 1257 Minutes |
| Figure 8 Suture - LARGE-BORE PROCEDURES | Time to Discharge (TTD)/Length of Stay (LOS) | 1338 Minutes |