PARADIGMDurAVR® Valve for Severe Aortic Stenosis
TAVR with DurAVR® THV
+ TAVR with SAPIEN THV series or the Evolut THV series
Aortic Valve Disease+3
+ Aortic Valve Stenosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: October 1, 2025
Actual date on which the first participant was enrolled.This study is designed to evaluate a new heart valve system called the DurAVR® THV, which is specifically engineered for better blood flow, against other commercially available heart valves used in procedures known as Transcatheter Aortic Valve Replacement (TAVR). The focus is on patients with severe calcification of their aortic valve, a condition that hinders blood flow from the heart. The study aims to enroll up to 1,054 participants who will be randomly assigned to either receive the DurAVR® valve or one of the existing valve options from the SAPIEN or Evolut series. The goal is to compare the safety and effectiveness of these options for improving heart function, which is important for enhancing the quality of life in patients with this heart condition. Participants in the main group will receive their assigned valve through a minimally invasive procedure. They will be monitored over a 10-year period to track their heart health and any potential complications. In addition, the study includes a separate group of up to 150 patients who have previously received a surgical valve that is no longer functioning well. These patients, considered high-risk for further surgery, will receive the new DurAVR® valve and be followed for 5 years. The outcomes of interest include how well the valves improve heart function and the durability of the valve over time. This long-term study helps ensure a thorough understanding of the new valve's performance and any risks involved.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1650 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Native Aortic Stenosis Cohorts: 1. The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System. 2. The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis. 3. Subject understands the study requirements and the treatment procedure and provides written informed consent. ViV Registry Cohort: 1. Severe degeneration of a surgically implanted aortic bioprosthetic valve. 2. Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team. 3. Subject understands the study requirements and the treatment procedure and provides written informed consent. Exclusion Criteria: Native Aortic Stenosis Cohorts: 1. Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis. 2. Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control). 3. Evidence of an acute myocardial infarction 30 days before randomization. 4. AV is unicuspid, Type 0 bicuspid, or is non-calcified. 5. Severe total aortic regurgitation 6. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis. 7. Pre-existing mechanical or bioprosthetic valve in any position. 8. Untreated clinically significant coronary artery disease (CAD) requiring revascularization. 9. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation. 10. Active bacterial endocarditis in the last 3 months. 11. Estimated life expectancy (after TAVR) \<12 months. 12. Subject is not a candidate for both arms (investigational and control) of the study. 13. Subject belongs to a vulnerable population ViV Registry Cohort: 1. Anatomy precluding safe placement of DurAVR THV. 2. Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position. 3. Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis 4. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation. 5. Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact. 6. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment. 7. Untreated clinically significant coronary artery disease (CAD) requiring revascularization. 8. Need for emergency surgery for any reason 9. GI bleeding within the past 3 months. 10. Active bacterial endocarditis in the last 3 months. 11. Estimated life expectancy (after TAVR) \<12 months. 12. Subject belongs to a vulnerable population.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives