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The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Registered Patients | Experimental | All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System | Device | The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization. | Within 24 hours of procedure. |
| Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications. | Within 24 hours of procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjaya K Gupta, MD | St. Luke's Hospital | Principal Investigator |
| Soroosh Kiani, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States | ||
| St. Luke's Hospital |
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A total of 36 subjects will be registered at 2 US investigational sites. All subjects must have femoral duplex ultrasound (DUS) at discharge and at a 30-dayfollow-up visit (if any access site-related vascular complications(either symptomatic/visible or asymptomatic/nonvisible), nerve injury, or infection at discharge, by either the investigator or the core laboratory).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Registered Patients | All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide suture-mediated closure (SMC) System and/or Perclose ProStyle suture-mediated closure and repair (SMCR) System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study enrolled a total of 36 subjects at 2 investigational sites.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Registered Patients | All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure. |
| 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 | Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | Within 24 hours of procedure. |
|
30 days
The data reported/presented under Outcome Measure 2 is a list of "vascular complications", whereas data reported under "Other (Not Including Serious) Adverse Events" section is a list of adverse events. In this study, there was 1 subject with deep vein thrombosis (DVT) that was identified by the site, reported as adverse event, and adjudicated by the CEC. In addition, there were 2 subjects that had DVT identified by the DUS core lab but not identified by the site.
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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 | All Registered Patients | All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System. Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System: The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophagitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular Access | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Pingle | Abbott Vascular | 858-222-9673 | sandeep.pingle1@abbott.com |
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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 | Mar 30, 2022 | Jul 12, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Kansas City |
| Missouri |
| 64111 |
| United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Arrhythmia | Count of Participants | Participants |
|
|
|
| Primary | Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Count of Participants | Participants | Within 24 hours of procedure. |
|
|
|
| 0 |
| 36 |
| 1 |
| 36 |
| 5 |
| 36 |
| Site Haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Venous Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
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| Pseudoaneurysm |
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| Arteriovenous (AV) Fistula |
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| Venous Tear |
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| Venous Perforation |
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| Arterial Tear |
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| Arterial Perforation |
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| Other Vascular Complication |
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| Arterial Stenosis |
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| Arterial Dissection |
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| Mobile Perclose Common Femoral Vein |
|