Severe Symptomatic Aortic Stenosis Clinical Trial
— Inop AAOfficial title:
Transcatheter Valve Therapy (TVT) Registry Assessment of Alternative Access Approaches for Transcatheter Aortic Valve Replacement (TAVR) in Inoperable Patients With Severe Aortic Stenosis
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN device compare to inoperable patients undergoing alternative access TAVR with the Edwards SAPIEN device experience a reasonably similar incidence of 30 day adverse events?
Status | Completed |
Enrollment | 8 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or older - Primary indication is symptomatic primary severe aortic stenosis predicted to benefit from relief of valvular stenosis - Aortic valve area less than 0.8 centimeters squared - Mean aortic valve gradient greater than or equal to 40 mmHG - Peak aortic jet velocity greater than or equal to 4.0 m per second - Valve sheath access site is femoral, axillary, transapical, transaortic, subclavian or subaxillary - Patient is judged by the local heart team to be inoperable for Aortic Valve Replacement due to severe chest wall deformities or radiation effects, severe peripheral or aortic vascular disease, or severe systemic disease prohibiting the safe conduct of Cardiopulmonary Bypass (CPB) Exclusion Criteria: - Aortic valve annulus size is less than 18 mm or greater than 25 mm - Active infectious endocarditis - Valve in prosthetic valve procedure - Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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The Society of Thoracic Surgeons | American College of Cardiology |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiac and cerebrovascular events | Increase in the 30-day risk of adverse events among patients receiving TAVR; Modified 30 day Valve Academic Research Consortium (VARC) Composite Early Safety Endpoint | 30 day | Yes |
Primary | Mortality | Proportion of patients who are alive with at least moderate functional improvement (defined as at least 10 point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline) at 1 year after TAVR | 1 year | No |
Secondary | 30-day endpoints for major morbidity | Endpoints include: mortality, stroke, stroke or transient ischemic attack (TIA), major vascular complications, valve-related dysfunction requiring re-intervention, incident renal replacement therapy, life-threatening bleeding, and high-degree aortic valve (AV) block requiring permanent pacemaker implantation | 30 day | Yes |
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