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This prospective, randomized, parallel, single-center, open-label, non-inferiority study will evaluate the safety and potential complications of dual ProGlide vs single ProGlide and Angioseal for common femoral arteriotomy closure following Transcatheter Aortic Valve Replacement.
This is a prospective, randomized, parallel, open-label, single-center, non-inferiority study.
Approximately 90 patients undergoing Transcatheter Aortic Valve Replacement with femoral access will be randomized in a 1:1 fashion to receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal for closure.
The primary end point of this study is the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication. Secondary end points include periprocedural complications (such as acute vessel closure, leg embolization and perforation), procedural characteristics (total duration, fluoroscopy time, contrast volume, length of hospital stay), and cost of hospitalization. A routine follow-up visit assessment will be performed at 30 days in the valve clinic and the assessment will include: any clinical change, re-interventions, and peripheral pulse evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Perclose Proglide | Active Comparator | Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices. |
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| Single Perclose Proglide plus Angioseal | Active Comparator | Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Perclose Proglide | Device | Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices. |
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| Measure | Description | Time Frame |
|---|---|---|
| Main Access-related Bleeding and Vascular Complications | Primary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria. | Periprocedural through hospital discharge, an average of 1.5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural Complications | A secondary endpoint will be the number of participants with periprocedural complications including acute vessel closure, leg embolization, or vessel perforation/dissection. | Periprocedural through hospital discharge, an average of 1.5 days |
| Procedural Total Duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White The Heart Hospital - Plano | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27173868 | Background | Kiramijyan S, Magalhaes MA, Ben-Dor I, Koifman E, Escarcega RO, Baker NC, Torguson R, Okubagzi P, Bernardo NL, Satler LF, Pichard AD, Waksman R. The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement. EuroIntervention. 2016 May 17;12(1):88-93. doi: 10.4244/EIJV12I1A16. | |
| 31155328 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dual Perclose Proglide | Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices. Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices. |
| FG001 | Single Perclose Proglide Plus Angioseal |
| 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 | Dec 13, 2024 |
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| Single Perclose Proglide plus Angioseal | Device | Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device. |
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Total procedure duration from procedure start to completion. |
| Periprocedural, around 1.5 hours |
| Fluoroscopy Time | Total fluoroscopy time will be measured from procedure start to completion. | Periprocedural, around 1.5 hours |
| Contrast Volume | Total contrast volume will be measured from the start of the procedure until completion. | Periprocedural, about 1.5 hours |
| Length of Hospital Stay | The length of the hospital stay will be collected. | From patient arrival until discharge, about 1.5 days |
| Cost of Hospital Stay | The cost of the hospital stay will be collected. | Patient arrival to discharge, about 1.5 days |
| Minor Vascular Complications | The number of participants with minor vascular complications will be collected | Periprocedural, about 1.5 hours |
| Need for Secondary Closure Device | The number of participants with the need for a secondary closure device will be collected. | Periprocedural, about 1.5 hours |
| Ko TY, Kao HL, Liu YJ, Yeh CF, Huang CC, Chen YH, Hung CS, Chan CY, Lin LC, Chen YS, Lin MS. Intentional combination of ProGlide and Angio-Seal for femoral access haemostasis in transcatheter aortic valve replacement. Int J Cardiol. 2019 Oct 15;293:76-79. doi: 10.1016/j.ijcard.2019.05.055. Epub 2019 May 23. |
| 31713996 | Background | Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 12. |
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device. Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dual Perclose Proglide | Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices. Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices. |
| BG001 | Single Perclose Proglide Plus Angioseal | Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device. Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device. |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Main Access-related Bleeding and Vascular Complications | Primary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria. | Posted | Number | Participants | Periprocedural through hospital discharge, an average of 1.5 days |
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| Secondary | Periprocedural Complications | A secondary endpoint will be the number of participants with periprocedural complications including acute vessel closure, leg embolization, or vessel perforation/dissection. | Posted | Number | Participants | No | Periprocedural through hospital discharge, an average of 1.5 days |
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| Secondary | Procedural Total Duration | Total procedure duration from procedure start to completion. | Posted | Median | Inter-Quartile Range | Minutes | Periprocedural, around 1.5 hours |
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| Secondary | Fluoroscopy Time | Total fluoroscopy time will be measured from procedure start to completion. | Posted | Median | Inter-Quartile Range | Minutes | Periprocedural, around 1.5 hours |
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| Secondary | Contrast Volume | Total contrast volume will be measured from the start of the procedure until completion. | Posted | Median | Inter-Quartile Range | milliliters | Periprocedural, about 1.5 hours |
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| Secondary | Length of Hospital Stay | The length of the hospital stay will be collected. | Posted | Median | Inter-Quartile Range | Days | From patient arrival until discharge, about 1.5 days |
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| Secondary | Cost of Hospital Stay | The cost of the hospital stay will be collected. | Posted | Mean | Standard Deviation | Dollars | Patient arrival to discharge, about 1.5 days |
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| Secondary | Minor Vascular Complications | The number of participants with minor vascular complications will be collected | Posted | Number | Participants | Periprocedural, about 1.5 hours |
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| Secondary | Need for Secondary Closure Device | The number of participants with the need for a secondary closure device will be collected. | Posted | Number | Participants | Periprocedural, about 1.5 hours |
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Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.
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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 | Dual Perclose Proglide | Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices. Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices. | 1 | 47 | 1 | 47 | 2 | 47 |
| EG001 | Single Perclose Proglide Plus Angioseal | Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device. Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device. | 0 | 42 | 0 | 42 | 0 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure with interstital lung disease and viral infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Acute chronic hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Ostergren | Baylor Scott & White Research Institute | 469-814-4181 | Bonnie.Ostergren@bswhealth.org |
| Jan 13, 2026 |
| Prot_SAP_000.pdf |
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| >=65 years |
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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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