Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 18-H-N045 |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcaval access and closure with the transcaval closure device (TCD) test article. | Experimental | All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcaval closure device (TCD) | Device | Transcaval access and closure using the Transmural Transcaval Closure Device (TCD) at the time of medically-necessary transcatheter aortic valve replacement (TAVR). |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 minute following procedure discharge (Exit from the catheterization laboratory) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert J Lederman, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31629746 | Derived | 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. |
Not provided
Not provided
The authors are willing to share de-identified subject data upon reasonable request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article | All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Feb 12, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 minute following procedure discharge (Exit from the catheterization laboratory) |
| 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:
Intended performance of the TCD, including all of:
| 30 days and 12 Months |
| 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:
| 30 Days |
| 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. | During procedure, procedure may last from 2 to 4 hours |
| 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 | During procedure, procedure may last from 2 to 4 hours |
| 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. | 30 Days |
| 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 | 30 days |
| 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 | 30 Days |
| 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. | Day 30 |
| 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:
| 30 Days and 12 Months |
| 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) | 30 Days |
| 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). | Day 30, 12 months |
| 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) | 30 Days |
| 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 | Day 30, 12 Months |
| 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) | 30 Days |
| 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) | 30 Days |
| 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) | Day 30 |
| 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 | Enrollment |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article | All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Ineligible for transfemoral access | Count of Participants | Participants |
|
| 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 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:
| Posted | Count of Participants | Participants | 1 minute following procedure discharge (Exit from the catheterization laboratory) |
|
|
| |||||||||||||||||||||||||||
| Secondary | 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:
| Posted | Count of Participants | Participants | 1 minute following procedure discharge (Exit from the catheterization laboratory) |
|
| ||||||||||||||||||||||||||||
| Secondary | 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:
Intended performance of the TCD, including all of:
| Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts. | Posted | Count of Participants | Participants | No | 30 days and 12 Months |
|
| ||||||||||||||||||||||||||
| Secondary | 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:
| Intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | During procedure, procedure may last from 2 to 4 hours |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | During procedure, procedure may last from 2 to 4 hours |
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | intention-to-treat (ITT) analysis | Posted | Number | participants | 30 days |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | Day 30 |
|
| |||||||||||||||||||||||||||
| Secondary | 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:
| Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts. For 12 months analysis, one participant died and one participant taken off study due to noncompliance. | Posted | Count of Participants | Participants | 30 Days and 12 Months |
|
| |||||||||||||||||||||||||||
| Secondary | 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) | Posted | Count of Participants | Participants | 30 Days |
|
| ||||||||||||||||||||||||||||
| Secondary | 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). | Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts. For month 12, one participant died and one participant taken off study due to noncompliance. | Posted | Count of Participants | Participants | Day 30, 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | 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) | intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Intention-to-treat (ITT) analysis. One participant died on post-procedure day 15 from respiratory failure attributed to exacerbation of previously unrecognized fibrotic pulmonary disease, adjudicated as noncardiovascular mortality and unrelated to transcaval access or TAVR. One participant at month 12 was taken off study due to non-compliance. | Posted | Count of Participants | Participants | Day 30, 12 Months |
|
| |||||||||||||||||||||||||||
| Secondary | 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) | intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||
| Secondary | 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) | intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | 30 Days |
|
| |||||||||||||||||||||||||||
| Secondary | 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) | intention-to-treat (ITT) analysis | Posted | Count of Participants | Participants | Day 30 |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | One participant is under 65 years of age and not included. | Posted | Count of Participants | Participants | Enrollment |
|
|
12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article | All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD). | 1 | 12 | 9 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Cardiac Chest pain | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Mobitz (type) II atrioventricular block | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE | Systematic Assessment |
| |
| C. Difficile infection | Infections and infestations | CTCAE | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| Arterial thromboembolism | Vascular disorders | CTCAE | Systematic Assessment |
| |
| Labile blood pressure | Vascular disorders | CTCAE | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Mild AVR paravalvular leak | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Moderate PV aortic regurgitation | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Cardiac Chest pain | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | CTCAE | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE | Systematic Assessment |
| |
| Fever | General disorders | CTCAE | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| Left femoral hematoma | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| Right groin oozing | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| Small right groin hematoma | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| Head laceration with fall | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE | Systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE | Systematic Assessment |
| |
| Haptoglobin decreased | Investigations | CTCAE | Systematic Assessment |
| |
| Elevated BNP | Investigations | CTCAE | Systematic Assessment |
| |
| Elevated BUN | Investigations | CTCAE | Systematic Assessment |
| |
| Elevated Haptoglobin | Investigations | CTCAE | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE | Systematic Assessment |
| |
| In-situ squamous cell carcinoma lesion on right dorsal forearm. | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
| |
| Arterial thromboembolism | Vascular disorders | CTCAE | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE | Systematic Assessment |
| |
| Superficial thrombophlebitis | Vascular disorders | CTCAE | Systematic Assessment |
|
The clinical trial was put suspended due to device needing to be redesign however funding never materialized to support the redesign, therefore, clinical trials was terminated early.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Lederman, Principal Investigator | National Heart, Lung, and Blood Institute (NHLBI) | 301.402.6769 | ledermar@nhlbi.nih.gov |
| Nov 7, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cardiovascular Deaths : Unrelated to Transcaval Closure Device |
| |||||
| Cardiovascular Deaths : At least possibly related to Transcaval Closure Device |
| |||||
| Non-Cardiovascular Deaths : Unrelated to Transcaval Closure Device |
| |||||
| Non-Cardiovascular Deaths : At least possibly related to Transcaval Closure Device |
|
|
|
|
|
|
|
|