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| Name | Class |
|---|---|
| Montreal Heart Institute | OTHER |
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This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.
This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route.
In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SoloPath Sheath | The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access |
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| Measure | Description | Time Frame |
|---|---|---|
| Vascular Access Site Complications | Rate of VARC-2 defined vascular complications within 30 days of TAVI. | withn 30 days of TAVI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Complications at the Access Site | VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding | within 30 days of TAVI procedure |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of subjects with severe aortic stenosis who underwent TAVI utilizing the SoloPath sheath for vascular access since 2011.
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| Name | Affiliation | Role |
|---|---|---|
| Anita Asagr, M.D. | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Ontario | Canada |
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Recruitment occurred between October 7th, 2014 and February 9th, 2015 at the Montreal Heart Institute.
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| ID | Title | Description |
|---|---|---|
| FG000 | SoloPath Sheath | The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SoloPath Sheath | The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access |
| 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 |
| 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 | Vascular Access Site Complications | Rate of VARC-2 defined vascular complications within 30 days of TAVI. | Posted | Number | participants | withn 30 days of TAVI procedure |
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Adverse events were not assessed as this was a retrospective study.
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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 | SoloPath Sheath | The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access. |
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Single center, retrospective data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gash, Director of Clinical Affairs | Terumo Medical Corporation | 732-302-4931 | robert.gash@terumomedical.com |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Bleeding Complications at the Access Site | VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding | Posted | Number | participants | within 30 days of TAVI procedure |
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PI shall be permitted to publish the results of the study in a manner that fairly and accurately sets forth the conclusions reached. The party seeking publication shall submit to the sponsor for review a draft of the proposed publication at least thirty (30) days prior to submission of the draft for publication.