NCT07194265招募中不适用
A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,650
- 试验地点
- 14
- 主要终点
- Composite of all-cause mortality, all stroke and cardiovascular hospitalization
研究概览
简要总结
Prospective, randomized, controlled, multicenter, international study.
Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years.
After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'.
Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Native Aortic Stenosis Cohorts:
- •The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
- •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.
- •Subject understands the study requirements and the treatment procedure and provides written informed consent.
- •ViV Registry Cohort:
- •Severe degeneration of a surgically implanted aortic bioprosthetic valve.
- •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.
- •Subject understands the study requirements and the treatment procedure and provides written informed consent.
排除标准
- •Native Aortic Stenosis Cohorts:
- •Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
- •Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
- •Evidence of an acute myocardial infarction 30 days before randomization.
- •AV is unicuspid, Type 0 bicuspid, or is non-calcified.
- •Severe total aortic regurgitation
- •Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
- •Pre-existing mechanical or bioprosthetic valve in any position.
- •Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
- •Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
- •Active bacterial endocarditis in the last 3 months.
- •Estimated life expectancy (after TAVR) <12 months.
- •Subject is not a candidate for both arms (investigational and control) of the study.
- •Subject belongs to a vulnerable population
- •ViV Registry Cohort:
- •Anatomy precluding safe placement of DurAVR THV.
- •Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.
- •Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
- •Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.
- •Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
- •Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
- •Need for emergency surgery for any reason
- •GI bleeding within the past 3 months.
- •Active bacterial endocarditis in the last 3 months.
- •Estimated life expectancy (after TAVR) <12 months.
- •Subject belongs to a vulnerable population.
研究组 & 干预措施
DurAVR THV
Experimental
DurAVR® THV implantation
干预措施: TAVR with DurAVR® THV (Device)
Control
Active Comparator
SAPIEN THV series or the Evolut THV series implantation
干预措施: TAVR with SAPIEN THV series or the Evolut THV series (Device)
结局指标
主要结局
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
时间窗: 1 Year
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
时间窗: 1 Year
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
次要结局
- All-cause mortality(30 Days)
- Disabling stroke according to VARC-3 Guidelines(30 Days)
- Life-threatening bleeding according to VARC-3 Guidelines(30 Days)
- Major vascular complication according to VARC-3 Guidelines(30 Days)
- Acute Kidney Injury (Stage III or IV) according to VARC-3 Guidelines(30 Days)
研究者
研究点 (14)
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相关资讯
Anteris Technologies Initiates U.S. Enrollment in PARADIGM Trial for Novel Biomimetic Heart Valve- Anteris Technologies has secured CMS reimbursement eligibility for its PARADIGM Trial under the TAVR National Coverage Determination, facilitating U.S. site activation for the pivotal study.
- The first U.S. patients have been successfully enrolled and treated in the PARADIGM Trial at Montefiore Medical Center, marking a significant milestone for the global study.
- The PARADIGM Trial will evaluate the DurAVR® THV, the first biomimetic transcatheter heart valve, against commercially available TAVRs in approximately 1,000 patients with severe calcific aortic stenosis.
- The study aims to assess non-inferiority on a primary composite endpoint of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure.4 months agoAnteris Technologies Raises $200 Million to Advance Aortic Stenosis Treatment with Strategic Medtronic Partnership- Anteris Technologies completed a $200 million public offering at $5.75 per share to fund its DurAVR transcatheter heart valve development program.
- Medtronic made a strategic investment of up to $90 million through a private placement, acquiring 16-19.99% ownership stake in the structural heart company.
- The funding will support the ongoing PARADIGM Trial for the biomimetic DurAVR valve system targeting patients with severe aortic stenosis.
- The DurAVR valve features ADAPT anti-calcification tissue technology that has been used in over 55,000 patients worldwide over the past decade.7 months agoAnteris Technologies Receives European Regulatory Clearance for DurAVR Global Pivotal Trial in Aortic Stenosis- Anteris Technologies received regulatory clearance from the Danish Medicines Agency to initiate the global PARADIGM Trial for its DurAVR transcatheter heart valve in patients with severe calcific aortic stenosis.
- The prospective randomized controlled trial will enroll approximately 1,000 patients to evaluate the safety and effectiveness of the biomimetic DurAVR valve compared to commercially available TAVR devices.
- Patient recruitment at Danish centers is expected to begin in Q4 2025, with planned expansion across the United States, Europe, and Canada pending additional regulatory approvals.
- The trial aims to support both PMA and CE Mark approvals for the DurAVR valve, which features patented anti-calcification tissue technology used in over 55,000 patients worldwide.11 months ago