Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Enrollment
- 172
- Locations
- 15
- Primary Endpoint
- The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Detailed Description
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have no good options for standard percutaneous femoral access or for standard surgical access to the cardiac apex or to the ascending aorta. In this prospective registry we will collect data from multiple medical centers as they offer transcaval TAVR to patients with extreme or prohibitive risk of conventional TAVR.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
Time Frame: 1 year
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access