Brief Summary
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.
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.
Brief Title
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Central Contacts
Central Contact Role
Contact
Central Contact Phone
612 895 5257
Central Contact Email
JEnglund@anteristech.com
Completion Date
Completion Date Type
Estimated
Conditions
Severe Aortic Stenosis
Valve-in-valve Procedures
Eligibility 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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
tavr
severe calcific aortic stenosis
failed surgical bioprosthesis
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07194265
Org Class
Industry
Org Full Name
Anteris Technologies Ltd.
Org Study Id
SP0083
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices
Primary Outcomes
Outcome Description
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Outcome Measure
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Outcome Time Frame
1 Year
Secondary Outcomes
Outcome Description
Mortality from any cause will by collected by tracking patient's living status via medical record
Outcome Time Frame
30 Days
Outcome Measure
All-cause mortality
Outcome Description
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Outcome Time Frame
30 Days
Outcome Measure
Disabling stroke according to VARC-3 Guidelines
Outcome Description
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Outcome Time Frame
30 Days
Outcome Measure
Life-threatening bleeding according to VARC-3 Guidelines
Outcome Description
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Outcome Time Frame
30 Days
Outcome Measure
Major vascular complication according to VARC-3 Guidelines
Outcome Description
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Outcome Time Frame
30 Days
Outcome Measure
Acute Kidney Injury (Stage III or IV) according to VARC-3 Guidelines
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andrea Scotti
Investigator Email
ascotti@montefiore.org
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
Montefiore
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- HEART VALVE DISEASES
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
AORTIC VALVE STENOSIS
AORTIC VALVE, CALCIFICATION OF
AORTIC VALVE DISEASE
HEART VALVE DISEASES
HEART DISEASES
CARDIOVASCULAR DISEASES
VENTRICULAR OUTFLOW OBSTRUCTION