D. Craig Miller, M.D.
Transcatheter Aortic Valve Replacement
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Aortic valve stenosis (AS) is a heart disease caused by the incomplete opening of the aortic valve in the heart. The aortic valve controls the direction of blood flow from the left ventricle (chamber of the heart) to the aorta (the major blood vessel the supplies blood to the whole body). Under some circumstances, the aortic valve becomes narrower than normal, impeding the flow of blood. This is known as aortic valve stenosis, or aortic stenosis. The more constricted the valve, the more the blood flow is impeded. This can cause life-threatening impairment of heart function. Medications and balloon valve angioplasty (inflating a balloon in the valve to increase the opening) can provide some relief of AS, but aortic valve replacement (AVR) is the only effective treatment in adults with severe symptomatic aortic stenosis to improve long-term survival. AVR surgery is a major open-chest procedure that carries significant risk for any patient. For some patients the risk is greater due to their age or other additional medical conditions, the risk is too great to undergo surgery. The Edwards SAPIEN? THV transcatheter aortic valve replacement is an investigative device that can insert a replacement valve into the area of the patient?s own aortic valve without the use of open-chest surgery. The valve is placed either through a small puncture in the artery of the leg, or a small incision in the side of the chest. Both approaches are considered to be less invasive than surgery. This study will evaluate the safety, effectiveness, and cost utilization of this system as compared to open-chest AVR surgery or medical management.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: Aortic Valve Replacement
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Cohort A
1. Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is greater or equal to 15% and/or a minimum STS score of 10
2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area of < 0.8 cm2
3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
4. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and
6. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.
Key Exclusion Criteria:
1. Evidence of an acute myocardial infarction less than or equal to 1 month before the intended treatment
2. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation)
5. Pre-existing prosthetic heart valve in any position, prosthetic ring, severe mitral annular calcification (MAC), severe (greater than 3+) mitral insufficiency, or Gorlin syndrome (conundrum)
6. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy
7. Untreated clinically significant coronary artery disease requiring revascularization
8. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
9. Need for emergency surgery for any reason
10. Hypertrophic cardiomyopathy with or without obstruction
11. Severe ventricular dysfunction with LVEF <20
12. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
13. Active peptic ulcer or upper GI bleeding within the prior 3 months
14. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
15. Native aortic annulus size < 18mm or > 25mm per the baseline echo as estimated by the LVOT
16. Patient has been offered surgery but has refused surgery
17. Recent (within 6 months) CVA or a TIA
18. Renal insufficiency (creatinine > 3.0) and/or end stage renal disease requiring chronic dialysis
19. Life expectancy < 12 months due to non-cardiac co-morbid conditions
20. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick , > 5 mm, protruding or ulcerated)or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta(applicable for transfemoral patients only)
21. Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F introducer sheath such as severe obstructive calcification, severe tortuosity or vessels size less than 7 mm in diameter(applicable for transfemoral patients only)
22. Currently participating in an investigational drug or another device study.
23. Active bacterial endocarditis or other active infections
24. Bulky calcified aortic valve leaflets in close proximity to the coronary ostia.
Additional Study Details
Official Title:
The Edwards SAPIEN? Transcatheter Heart Valve, Model 9000TFX The PARTNER (US) Trial: Placement of AoRtic TraNscathetER Valves Trial with CONTINUED ACCESSAnticipated start date:
9/1/2008Lead Sponsor:
Edwards Lifesciences LLCInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Cohort A: Freedom from Death (non-inferioroty)
- (1) Freedom from death, over the duration of the trial(superiority) and (2) Composite of death and recurrent hospitalization, using the method of Finkelstein and Schoenfeld.
Secondary Outcomes:
- Functional improvement from baseline as measured per (EOA) and c) six minute walk test
- Freedom from MACCE
- Evidence of prosthetic valve dysfunction
- Length of index hospital stay
- Total hospital days from the index procedure
- Improved Quality of Life (QOL) from baseline
- Improved valve function
- Functional improvement from baseline as measured per a) NYHA functional classification, b) effective orifice area (EOA) and c) six minute walk test
- Freedom from MACCE
- Total hospital days from the index procedure or randomization into control arm for medical management patients
- Improved Quality of Life (QOL) from baseline
- Improved valve function
Total Number to be Enrolled:
1040Total Number to be Enrolled at Stanford:
0More Information
Secondary ID(s):
- SPO 43002
- eprotocol 14810
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
10/22/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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