U.S., Sept. 27 -- ClinicalTrials.gov registry received information related to the study (NCT07194265) titled 'Clinical Trial Assessing the Safety and Effectiveness of the DurAVR(R) THV System' on Sept. 05.
Brief Summary: Prospective, randomized, controlled, multicenter, international study.
Subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for TAVR, will be will be enrolled in the 'All Comers Randomized Cohort'. They will be randomized 1:1 to receive either the DurAVR(R) THV System or any commercially available and approved THV from the SAPIEN series or the Evolut serie and followed for 10 years.
Subjects with a failed surgical bioprosthesis who are deemed high surgica...