Back to resultsTransmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Primary Purpose
Aortic Stenosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcaval closure device (TCD)
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis focused on measuring Transcatheter, Transcaval, Bioprosthesis, Closure Device, Aortic Stenosis
Eligibility Criteria
- INCLUSION CRITERIA:
- Consents to participate in this study and all related clinical follow-up procedures
- Adults age greater than or equal to 21 years
- Undergoing transcatheter aortic valve replacement (TAVR) based on the clinical assessment of the multidisciplinary heart team
- Ineligible for femoral artery access for the selected transcatheter heart valve (THV) according to the THV manufacturer instructions for use. (Note Corevalve Evolut R: greater than or equal to 5mm; Evolut PRO 23, 26, 29 mm valves and Evolut R 34 mm: greater than or equal to 5.5 mm; Edwards Sapien 3, 23-26mm: 5.5 mm; Edwards Sapien 3, 29mm: 6.0mm; Anatomic ineligibility also considers patient-specific pattern of iliofemoral calcium and tortuosity.)
- Eligible for transcaval access based on Core lab analysis of the baseline abdomen/pelvis CT indicating a calcium-free target window on the abdominal aorta; a target greater than or equal to 15mm from the lowest main renal artery or aorto-iliac bifurcation; no important interposed structures; a projected intravascular centerline distance from the lower femoral head to the target at least 5cm less than the intended THV introducer sheath; patient celiac or superior mesenteric artery
- Aorta diameter greater than or equal to 11mm at the target crossing site
- Concordance of the study eligibility committee
EXCLUSION CRITERIA:
- High risk features on baseline CT including porcelain aorta (confluent calcification); pedunculated aortic atheroma; or leftward aortic angel greater than or equal to 20 degrees with regard to vertical.
- Renal dysfunction limiting follow-up contrast-enhanced CR (estimated glomerular filtration rate, eGFR less than 30mL/min/1.73m^2 if not already on renal replacement therapy)
- Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Sites / Locations
- MedStar Washington Hospital Center
- Emory University
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcaval access and closure with the transcaval closure device (TCD) test article.
Arm Description
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
Outcomes
Primary Outcome Measures
Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)
Number of participants with technical success of delivery of the transcaval closure device (TCD)
All of the following must be present for technical success:
Alive
Successful delivery of the TCD, and retrieval of the TCD delivery system
Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.
No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system
Adjunctive balloon aortic tamponade is permissible and consistent with technical success
Secondary Outcome Measures
Number of Participants With Closure Success of the Transcaval Closure Device (TCD)
Number of Participants With Technical Closure Success of Delivery of the Transcaval Closure Device (TCD). This secondary endpoint is a composite of the primary endpoint and hemostasis of the transcaval aortic access site.
All of the following must be present for Closure Success:
Alive
Successful delivery of the TCD, and retrieval of the TCD delivery system
Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.
No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success
Complete occlusion of the aortocaval fistula on the completion aortogram.
Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)
A key performance endpoint is the number of participants who experienced device success of the transcaval closure device (TCD).
All of the following must be present for device success:
Alive or Death unrelated to transcaval access or TAVR
Original intended TCD in place
No additional surgical or interventional procedures related to access or the device after exit from the cath lab
Intended performance of the TCD, including all of:
Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD
Hemodynamic performance: No abdominal aortic obstruction caused by the TCD implant
Absence of para-device complications (large retroperitoneal hematoma, pseudoaneurysm, distal thromboembolism, or pulmonary thromboembolism)
Number of Participants That Experienced Procedural Success
Number of participants that experienced safety endpoint of procedural success following transcaval closure device (TCD) at day 30.
All of the following must be present for procedural success:
Device success
No device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TCD requiring unplanned reintervention or surgery (such as covered stent implantation at the transcaval access site)
Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure
Number of participants requiring covered stent implantation as a normal provisional part of the procedure assessed during the procedure.
Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site
Number of participants with covered stent implantation at the transcaval closure device (TCD) implantation site
Number of Participants Final Acute Aorto-caval Fistula Score
Number of Participants final acute aorto-caval fistula score at procedure completion.
Scoring is defined as: Type 0=occlusion, Type 1=patent fistula, Type 2=cruci-form fistula pattern, Type 3=extravasation.
A score of 0 is associated with complete occlusion at the transcaval closure device (TCD) site while a higher score is associated with incomplete occlusion at the TCD site.
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications
Participants who experienced Minor or Major modified Valve Academic Research Consortium-2 (VARC-2) vascular complications.
Major is defined as: Aortic dissection or aortic rupture; Access site-related arterial or venous injury THAT RESULTS IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization requiring surgery or resulting in amputation or irreversible end-organ damage; severe access site vascular complication Minor is defined as: Access site-related arterial or venous injury THAT DOES NOT RESULT IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization treated with embolectomy and/or thrombectomy not resulting in amputation or irreversible end-organ damage; Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication; Vascular repair
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications
Number of Participants Who Experienced Major or Life-threatening Modified Valve Academic Research Consortium-2 (VARC-2) bleeding complications at 30 days
Major defined as: Corrected drop in the hemoglobin of >=3.0 g/dl AND does not meet criteria of life-threatening or extensive bleeding; Requiring transfusion of >=3 U of whole blood or packed RBCs AND does not meet criteria of life-threatening or extensive bleeding.
Life-threatening defined as: Intracranial requiring surgery or intervention; Intraspinal requiring surgery or intervention; Intraocular requiring surgery or intervention; Pericardial requiring surgery or intervention; Intramuscular with compartment syndrome; Bleeding causing hypovolemic shock or hypotension or requiring significant doses of vasopressors or surgery
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Number of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)
Major adverse cardiovascular events (MACE), defined as VARC-2 Early Safety composite: No mortality, stroke, life-threatening bleeding, acute kidney injury (AKI) stage 2+, major vascular complication, and valve-related complication.
Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)
Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD).
All of the following must be present for Closure Success:
Alive or Death unrelated to transcaval access or TAVR
Successful delivery of the TCD, and retrieval of the TCD delivery system
Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.
No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success
Complete occlusion of the aortocaval fistula on the completion aortogram.
All-Cause Mortality
All-cause mortality, as categorized by cardiovascular vs non-cardiovascular, peri- vs non-periprocedural, regardless of attribution to Transcaval Closure Device (TCD)
Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography
Number of participants with aorto-caval fistula patency at each timepoint, assessed combining completion angiography and arterial-phase follow-up Computed tomography (CT).
Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3
Number of participants who experienced acute kidney injury (AKI) stage 2 or 3 using the Valve Academic Research Consortium (VARC).
AKI using the VARC definition:
Stage 2: increase in serum creatinine to 200-300% (2.0-3.0 times increase compared to baseline) or increase of >0.3 mg/dl (>26.4 mmol/L) but <4.0 mg/dl (<354 mmol/L)
Stage 3: increase in serum creatinine to ≥300% (>3 times increase compared to baseline) or serum creatinine of ≥4.0 mg/dl (≥354 mmol/L), with acute increase of ≥0.5 mg/dl (44 mmol/L)
Number of Participants That Are Free From Infection Related to the Transcaval Closure Device
Number of participants that experience freedom from infection related to the Transcaval Closure Device (TCD) at each time point
Number of Participants That Experience Thrombocytopenia and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
Number of participants that experience Thrombocytopenia as defined as < 50,000 and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)
Number of Participants Who Experience Hemolysis and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
Number of participants who experience hemolysis and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)
Participant Cumulative Computed Tomography Analysis of Device
Participant cumulative Computed tomography (CT) analysis of device. As defined by: Device position; Device integrity; Aortocaval tract pseudo-aneurysm; Aortic pseudoaneurysm; Retroperitoneal hematoma grade (stranding {=absent and not evidence of overt bleeding;} small; moderate; larger); Intracaval mass or thrombus; Aortic dissection and inferred relatedness to TCD (adjacent to access port) or procedure (remote to access port)
Number of Participants Enrolled Greater Than 65 Years
Outcomes of subjects greater than 65 years (i.e. eligible for Medicare based on age), to determine generalizability to the Medicare population
Full Information
NCT ID
NCT03432494
First Posted
February 13, 2018
Last Updated
February 15, 2023
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03432494
Brief Title
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Official Title
Early Feasibility Evaluation of Transmural Systems Transcaval Closure Device (TCD) for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (TAVR)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The trial was kept open (via administrative hold) in anticipation of a device redesign and enrollment suspended, but funding never materialized to support the redesign.
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
Brief Summary
Background:
Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement. Not all patients are eligible for TAVR using standard access through the artery in the groin, because the artery is too small or too diseased. In this study, TAVR is performed using a new technique called transcaval access. The catheter is placed in the artery deep in the body by crossing through the wall of a deep vein. The connection between that vein and the aorta is closed with a new metallic device they are testing. This is called a transcaval closure device (TCD).
Objective:
To test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR.
Eligibility:
Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach
Design:
Participants will be assessed by heart experts including cardiologists and surgeons.
Participants will have TAVR by the transcaval approach. A small catheter will be passed between the largest vein in the body and the nearby largest artery (aorta), inside the abdomen. Through this catheter, the TAVR will be implanted in the usual way.
After, doctors will implant the TCD by catheter to close the hole made in the aorta.
Participants will be X-rayed. A dye will be injected to view the TCD device.
Participants will get standard TAVR care afterwards. They will have physical exams, blood tests, and scans.
Participants will have a follow-up scan within 1 month and after 12 months.
Participants will have follow-up visits and phone calls 6 and 12 months after the procedure.
Detailed Description
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) enables transcatheter aortic valve replacement (TAVR) in patients not eligible for femoral artery access. Currently the procedure is performed using devices, off-label, designed and marketed to close holes inside the heart and great vessels, manufactured by Abbott St Jude (Amplatzer Duct Occluder and Amplatzer Muscular VSD Occluder). Because these Amplatzer occluders are not designed to close transcaval access sites, they may not completely prevent bleeding.
This is an early feasibility study (EFS) evaluation of a purpose-built closure device for transcaval access. The device, the Transcaval closure device (TCD) will be evaluated for safety and performance to close transcaval access sites in patients ineligible for femoral artery access for TAVR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
Transcatheter, Transcaval, Bioprosthesis, Closure Device, Aortic Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcaval access and closure with the transcaval closure device (TCD) test article.
Arm Type
Experimental
Arm Description
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
Intervention Type
Device
Intervention Name(s)
Transcaval closure device (TCD)
Intervention Description
Transcaval access and closure using the Transmural Transcaval Closure Device (TCD) at the time of medically-necessary transcatheter aortic valve replacement (TAVR).
Primary Outcome Measure Information:
Title
Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)
Description
Number of participants with technical success of delivery of the transcaval closure device (TCD)
All of the following must be present for technical success:
Alive
Successful delivery of the TCD, and retrieval of the TCD delivery system
Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.
No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system
Adjunctive balloon aortic tamponade is permissible and consistent with technical success
Time Frame
1 minute following procedure discharge (Exit from the catheterization laboratory)
Secondary Outcome Measure Information:
Title
Number of Participants With Closure Success of the Transcaval Closure Device (TCD)
Description
Number of Participants With Technical Closure Success of Delivery of the Transcaval Closure Device (TCD). This secondary endpoint is a composite of the primary endpoint and hemostasis of the transcaval aortic access site.
All of the following must be present for Closure Success:
Alive
Successful delivery of the TCD, and retrieval of the TCD delivery system
Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.
No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success
Complete occlusion of the aortocaval fistula on the completion aortogram.
Time Frame
1 minute following procedure discharge (Exit from the catheterization laboratory)
Title
Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)
Description
A key performance endpoint is the number of participants who experienced device success of the transcaval closure device (TCD).
All of the following must be present for device success:
Alive or Death unrelated to transcaval access or TAVR
Original intended TCD in place
No additional surgical or interventional procedures related to access or the device after exit from the cath lab
Intended performance of the TCD, including all of:
Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD
Hemodynamic performance: No abdominal aortic obstruction caused by the TCD implant
Absence of para-device complications (large retroperitoneal hematoma, pseudoaneurysm, distal thromboembolism, or pulmonary thromboembolism)
Time Frame
30 days and 12 Months
Title
Number of Participants That Experienced Procedural Success
Description
Number of participants that experienced safety endpoint of procedural success following transcaval closure device (TCD) at day 30.
All of the following must be present for procedural success:
Device success
No device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TCD requiring unplanned reintervention or surgery (such as covered stent implantation at the transcaval access site)
Time Frame
30 Days
Title
Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure
Description
Number of participants requiring covered stent implantation as a normal provisional part of the procedure assessed during the procedure.
Time Frame
During procedure, procedure may last from 2 to 4 hours
Title
Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site
Description
Number of participants with covered stent implantation at the transcaval closure device (TCD) implantation site
Time Frame
During procedure, procedure may last from 2 to 4 hours
Title
Number of Participants Final Acute Aorto-caval Fistula Score
Description
Number of Participants final acute aorto-caval fistula score at procedure completion.
Scoring is defined as: Type 0=occlusion, Type 1=patent fistula, Type 2=cruci-form fistula pattern, Type 3=extravasation.
A score of 0 is associated with complete occlusion at the transcaval closure device (TCD) site while a higher score is associated with incomplete occlusion at the TCD site.
Time Frame
30 Days
Title
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications
Description
Participants who experienced Minor or Major modified Valve Academic Research Consortium-2 (VARC-2) vascular complications.
Major is defined as: Aortic dissection or aortic rupture; Access site-related arterial or venous injury THAT RESULTS IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization requiring surgery or resulting in amputation or irreversible end-organ damage; severe access site vascular complication Minor is defined as: Access site-related arterial or venous injury THAT DOES NOT RESULT IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization treated with embolectomy and/or thrombectomy not resulting in amputation or irreversible end-organ damage; Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication; Vascular repair
Time Frame
30 days
Title
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications
Description
Number of Participants Who Experienced Major or Life-threatening Modified Valve Academic Research Consortium-2 (VARC-2) bleeding complications at 30 days
Major defined as: Corrected drop in the hemoglobin of >=3.0 g/dl AND does not meet criteria of life-threatening or extensive bleeding; Requiring transfusion of >=3 U of whole blood or packed RBCs AND does not meet criteria of life-threatening or extensive bleeding.
Life-threatening defined as: Intracranial requiring surgery or intervention; Intraspinal requiring surgery or intervention; Intraocular requiring surgery or intervention; Pericardial requiring surgery or intervention; Intramuscular with compartment syndrome; Bleeding causing hypovolemic shock or hypotension or requiring significant doses of vasopressors or surgery
Time Frame
30 Days
Title
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Description
Number of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)
Major adverse cardiovascular events (MACE), defined as VARC-2 Early Safety composite: No mortality, stroke, life-threatening bleeding, acute kidney injury (AKI) stage 2+, major vascular complication, and valve-related complication.
Time Frame
Day 30
Title
Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)
Description
Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD).
All of the following must be present for Closure Success:
Alive or Death unrelated to transcaval access or TAVR
Successful delivery of the TCD, and retrieval of the TCD delivery system
Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure.
No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success
Complete occlusion of the aortocaval fistula on the completion aortogram.
Time Frame
30 Days and 12 Months
Title
All-Cause Mortality
Description
All-cause mortality, as categorized by cardiovascular vs non-cardiovascular, peri- vs non-periprocedural, regardless of attribution to Transcaval Closure Device (TCD)
Time Frame
30 Days
Title
Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography
Description
Number of participants with aorto-caval fistula patency at each timepoint, assessed combining completion angiography and arterial-phase follow-up Computed tomography (CT).
Time Frame
Day 30, 12 months
Title
Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3
Description
Number of participants who experienced acute kidney injury (AKI) stage 2 or 3 using the Valve Academic Research Consortium (VARC).
AKI using the VARC definition:
Stage 2: increase in serum creatinine to 200-300% (2.0-3.0 times increase compared to baseline) or increase of >0.3 mg/dl (>26.4 mmol/L) but <4.0 mg/dl (<354 mmol/L)
Stage 3: increase in serum creatinine to ≥300% (>3 times increase compared to baseline) or serum creatinine of ≥4.0 mg/dl (≥354 mmol/L), with acute increase of ≥0.5 mg/dl (44 mmol/L)
Time Frame
30 Days
Title
Number of Participants That Are Free From Infection Related to the Transcaval Closure Device
Description
Number of participants that experience freedom from infection related to the Transcaval Closure Device (TCD) at each time point
Time Frame
Day 30, 12 Months
Title
Number of Participants That Experience Thrombocytopenia and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
Description
Number of participants that experience Thrombocytopenia as defined as < 50,000 and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)
Time Frame
30 Days
Title
Number of Participants Who Experience Hemolysis and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
Description
Number of participants who experience hemolysis and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)
Time Frame
30 Days
Title
Participant Cumulative Computed Tomography Analysis of Device
Description
Participant cumulative Computed tomography (CT) analysis of device. As defined by: Device position; Device integrity; Aortocaval tract pseudo-aneurysm; Aortic pseudoaneurysm; Retroperitoneal hematoma grade (stranding {=absent and not evidence of overt bleeding;} small; moderate; larger); Intracaval mass or thrombus; Aortic dissection and inferred relatedness to TCD (adjacent to access port) or procedure (remote to access port)
Time Frame
Day 30
Title
Number of Participants Enrolled Greater Than 65 Years
Description
Outcomes of subjects greater than 65 years (i.e. eligible for Medicare based on age), to determine generalizability to the Medicare population
Time Frame
Enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Consents to participate in this study and all related clinical follow-up procedures
Adults age greater than or equal to 21 years
Undergoing transcatheter aortic valve replacement (TAVR) based on the clinical assessment of the multidisciplinary heart team
Ineligible for femoral artery access for the selected transcatheter heart valve (THV) according to the THV manufacturer instructions for use. (Note Corevalve Evolut R: greater than or equal to 5mm; Evolut PRO 23, 26, 29 mm valves and Evolut R 34 mm: greater than or equal to 5.5 mm; Edwards Sapien 3, 23-26mm: 5.5 mm; Edwards Sapien 3, 29mm: 6.0mm; Anatomic ineligibility also considers patient-specific pattern of iliofemoral calcium and tortuosity.)
Eligible for transcaval access based on Core lab analysis of the baseline abdomen/pelvis CT indicating a calcium-free target window on the abdominal aorta; a target greater than or equal to 15mm from the lowest main renal artery or aorto-iliac bifurcation; no important interposed structures; a projected intravascular centerline distance from the lower femoral head to the target at least 5cm less than the intended THV introducer sheath; patient celiac or superior mesenteric artery
Aorta diameter greater than or equal to 11mm at the target crossing site
Concordance of the study eligibility committee
EXCLUSION CRITERIA:
High risk features on baseline CT including porcelain aorta (confluent calcification); pedunculated aortic atheroma; or leftward aortic angel greater than or equal to 20 degrees with regard to vertical.
Renal dysfunction limiting follow-up contrast-enhanced CR (estimated glomerular filtration rate, eGFR less than 30mL/min/1.73m^2 if not already on renal replacement therapy)
Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Lederman, M.D.
Organizational Affiliation
National Heart, Lung, and Blood Institute (NHLBI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The authors are willing to share de-identified subject data upon reasonable request
Citations:
PubMed Identifier
31629746
Citation
Rogers T, Greenbaum AB, Babaliaros VC, Stine AM, Khan JM, Schenke WH, Eng MH, Paone G, Leshnower BG, Satler LF, Waksman R, Chen MY, Lederman RJ. Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing. JACC Cardiovasc Interv. 2019 Nov 11;12(21):2198-2206. doi: 10.1016/j.jcin.2019.05.053. Epub 2019 Oct 16.
Results Reference
derived
Learn more about this trial
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
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