Anteris Advances Global PARADIGM Trial Expansion with German Regulatory Clearance
Anteris received full regulatory clearance from Germany's BfArM to begin patient recruitment for its DurAVR THV global pivotal PARADIGM Trial in severe calcific aortic stenosis. Germany is Europe's largest TAVR market, and site activation there is expected to accelerate enrollment in the roughly 1,000-patient head-to-head randomized trial (NCT07194265).
Key figures
- Drug Name
- DurAVR Transcatheter Heart Valve (THV)
- Phase Of Trial
- Pivotal (global pivotal trial)
- Trial name
- PARADIGM Trial
- Clinicaltrials id
- NCT07194265
- Planned enrollment
- approximately 1,000 patients
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