Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access
Brief Summary: Background:

- Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use.

Objective:

- To further study the safety and effectiveness of transcaval TAVR.

Eligibility:

- Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable.

Design:

* Participants will be selected by a team of heart specialists and others.
* Participants will have a computed tomography (CT) scan with or without contrast dye.
* Participants will have blood tests.
* Participants will have transcaval TAVR.
* Participants will receive the same standard care as for all patients with TAVR.
* Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months.
* Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.


Options:
A: Arm Label: PIIA - SAPIEN XT; Type: EXPERIMENTAL; Interventions: Device: TAVR Implantation with SAPIEN XT | Arm Label: Control: SAVR; Type: ACTIVE_COMPARATOR; Interventions: Device: SAVR Implantation | Intervention Type: DEVICE; Name: TAVR Implantation with SAPIEN XT; Assigned to Arm(s): PIIA - SAPIEN XT | Intervention Type: DEVICE; Name: SAVR Implantation; Assigned to Arm(s): Control: SAVR
B: Arm Label: Transcatheter Aortic Valve Implantation; Type: EXPERIMENTAL; Interventions: Procedure: Transcatheter Aortic Valve Implantation | Arm Label: Surgical Aortic Valve Replacement; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Surgical Aortic Valve Replacement | Intervention Type: PROCEDURE; Name: Transcatheter Aortic Valve Implantation; Assigned to Arm(s): Transcatheter Aortic Valve Implantation | Intervention Type: PROCEDURE; Name: Surgical Aortic Valve Replacement; Assigned to Arm(s): Surgical Aortic Valve Replacement
C: Arm Label: A; Type: EXPERIMENTAL; Interventions: Procedure: CA-TAVR, Device: Amplatzer Duct Occluder | Intervention Type: PROCEDURE; Name: CA-TAVR; Assigned to Arm(s): A | Intervention Type: DEVICE; Name: Amplatzer Duct Occluder; Assigned to Arm(s): A
D: Arm Label: Medtronic Transcatheter Aortic Valve Replacement Systems; Type: EXPERIMENTAL; Interventions: Device: Medtronic Transcatheter Aortic Valve Replacement Systems | Arm Label: Surgical Aortic Valve Replacement (SAVR); Type: ACTIVE_COMPARATOR; Interventions: Device: Surgical Aortic Valve Replacement (SAVR) | Intervention Type: DEVICE; Name: Medtronic Transcatheter Aortic Valve Replacement Systems; Assigned to Arm(s): Medtronic Transcatheter Aortic Valve Replacement Systems | Intervention Type: DEVICE; Name: Surgical Aortic Valve Replacement (SAVR); Assigned to Arm(s): Surgical Aortic Valve Replacement (SAVR)

Answer: C