Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement

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. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system 5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success

Time frame: 1 minute following procedure discharge (Exit from the catheterization laboratory)

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

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

Population: One participant is under 65 years of age and not included.

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

Population: intention-to-treat (ITT) analysis

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

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

Population: 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.

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: 1. Device success 2. 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

Population: Intention-to-treat (ITT) analysis

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

Population: intention-to-treat (ITT) analysis

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

Population: intention-to-treat (ITT) analysis

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: 1. Alive or Death unrelated to transcaval access or TAVR 2. Original intended TCD in place 3. 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: 1. Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD 2. Hemodynamic performance: No abdominal aortic obstruction caused by the TCD implant 3. Absence of para-device complications (large retroperitoneal hematoma, pseudoaneurysm, distal thromboembolism, or pulmonary thromboembolism)

Time frame: 30 days and 12 Months

Population: 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.

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

Population: intention-to-treat (ITT) analysis

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

Population: intention-to-treat (ITT) analysis

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

Population: intention-to-treat (ITT) analysis

Number of participants who experience hemolysis and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)

Time frame: 30 Days

Population: intention-to-treat (ITT) analysis

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

Population: 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.

Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD). All of the following must be present for Closure Success: 1. Alive or Death unrelated to transcaval access or TAVR 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. 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 5. Complete occlusion of the aortocaval fistula on the completion aortogram.

Time frame: 30 Days and 12 Months

Population: 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.

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: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. 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 5. Complete occlusion of the aortocaval fistula on the completion aortogram.

Time frame: 1 minute following procedure discharge (Exit from the catheterization laboratory)

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

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

Population: intention-to-treat (ITT) analysis