PARADIGM Trial | The First Head-to-Head TAVR Trial of its Kind

ClinicalTrials.gov Identifier # NCT07194265

The PARADIGM Trial is evaluating the DurAVR® Transcatheter Heart Valve (THV)

The randomized head-to-head trial is evaluating the DurAVR® THV System compared to commercially available Transcatheter Aortic Valve Replacement (TAVR) devices in patients with severe aortic stenosis.

The First Head-to-Head TAVR Trial of its Kind

It is the first head-to-head TAVR trial to move beyond conventional endpoints of safety, efficacy, and hemodynamic performance—aiming to also uncover the clinical impact of restoring physiologic flow patterns. Patients enrolled in the study will be randomized to one of two groups. One group will receive the DurAVR® valve, and the other group will receive a commercially available TAVR valve.

For more information, visit clinicaltrials.gov

DurAVR® INVESTIGATIONAL USE ONLY. NOT AVAILABLE FOR COMMERCIAL SALE. EU: Exclusively for clinical investigations. US: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.

Eligibility Requirements

Patients should contact their physician to see if they are eligible for the clinical trial. The full list of eligibility criteria can be found at clinicaltrials.gov.

Native Aortic Stenosis Cohorts

Native calcific severe aortic stenosis
Patient is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV system
Patient provides informed consent and agrees to return for specific follow-up appointments and assessments

View full list of criteria

Our Technology

DurAVR® Transcatheter Heart Valve

DurAVR® THV is a first-in-class biomimetic valve built to mimic the performance of a healthy aortic valve. The valve has the potential to shift the paradigm of how we define success in aortic stenosis treatment.

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DurAVR® THV is designed to restore healthy flow

Unlike commercially available TAVR valves, the DurAVR® valve is built from a single piece of tissue that is molded to resemble the shape of a healthy human aortic valve. This shape is designed to restore blood flow through the valve to healthy laminar (straight) flow, allowing the heart to work more efficiently to pump blood to the rest of the body.

A newer imaging technique called 4D cardiac MRI can show doctors how the blood is flowing out of the aortic valve. A turbulent flow pattern (left) creates extra work for the heart and increases stress on the aorta. A healthy aortic valve has laminar (straight) blood flow, similar to the post-DurAVR® example (right).

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