Narrowed aortic heart valve. Symptomatic aortic heart valve stenosis
Conditions
Interventions
The randomized group will consist of two groups: One group will be eligible for
TAVR with the Lotus Valve and the other group will be eligible for TAVR with
the CoreValve. On average, 2 of every 3 p
Sponsors
Boston Scientific Cooperation International
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: IC1. Subject has documented calcific, severe native aortic stenosis with an initial AVA of =40 mm Hg or jet velocity >=4.0 m/s, as measured by echocardiography and/or invasive hemodynamics. IC2. Subject has a documented aortic annulus size of >=20 mm and = II. IC4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following. • Society of Thoracic Surgeons (STS) score >=8% -OR- • If STS 60 mmHg) o Prior chest radiation therapy o Coronary artery bypass graft(s) at risk with re-operation o Severe lung disease (need for supplemental oxygen, FEV1 6 seconds, Katz ADL score of 3/6 or less, body mass index =90 years o Other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition) IC5. Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement. IC6. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent. IC7. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits. Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk >=50% at 30 days. High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk >=15% at 30 days.;Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).
Exclusion criteria
Exclusion criteria: EC1. Subject has a congenital unicuspid or bicuspid aortic valve. EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation >= twice normal in the presence of CK-MB elevation and/or troponin elevation). EC3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment. EC4. Subject has end-stage renal disease or has GFR 700,000 cells/mm3, or white blood cell count 5 mm) protruding or ulcerated atheroma in the aortic arch EC22. Subject has arterial access that is not acceptable for the test and control device delivery systems as defined in the device Instructions For Use. EC23. Subject has current problems with substance abuse (e.g., alcohol, etc.). EC24. Subject is participating in another investigational drug or device study that has not reached its primary end
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoint: moderate or greater paravalvular aortic regurgitation (based on core lab assessment) at 1 year. | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications at 30 days. Primary Effectiveness Endpoint: Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment) at 1 year. | — |
Countries
Netherlands
Outcome results
None listed