This trial is active, not recruiting.

Condition critical aortic stenosis
Treatments edwards sapien transcatheter heart valve, surgical valve replacement, medical management and/or balloon aortic valvuloplasty
Sponsor Edwards Lifesciences
Start date April 2007
End date March 2017
Trial size 3285 participants
Trial identifier NCT00530894, 2006-06-US


The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Cohort A: Sapien Valve
edwards sapien transcatheter heart valve
(Active Comparator)
Cohort A: other surgical valve
surgical valve replacement
Cohort B: Sapien Valve
edwards sapien transcatheter heart valve
(Active Comparator)
Cohort B: Medical therapy
medical management and/or balloon aortic valvuloplasty

Primary Outcomes

Freedom from death (Cohort A: Edwards Sapien Valve{Transfemoral or Transapical} vs. other surgical valve)
time frame: 1 year
Freedom from Death (Cohort B: Edwards Sapien Valve{transfemoral} vs. medical therapy)
time frame: duration of study

Secondary Outcomes

Functional Improvement from baseline per NYHA functional classification (Cohort A and Cohort B)
time frame: 30 days, 6 months, 1 year
Freedom from MACCE and expanded safety composite events.
time frame: 30 days, 6 months, 1 year
Evidence of prosthetic valve dysfunction (hemolysis, infection, thrombosis, severe paravalvular leak, or migration) (Cohort A)
time frame: 30 days, 6 months, 1 year
Length of index hospital stay (Cohort A)
time frame: number of days hospitalized
Total hospital days from the index procedure to one year post procedure. (Cohort A)
time frame: 1 year
Improved Quality of Life (QOL) from baseline to 30 days, 6 months, and annually through year 5 (Cohort A and Cohort B)
time frame: 30 days, 6 months, years 1 - 5
Improved valve function demonstrated by a responder analysis showing the percentage of patients in each treatment group who have a greater than 50% improvement in AVA at 30 days, 6 months, and 12 months. (Cohort A and Cohort B)
time frame: 30 days, 6 months, 1 year
Total hospital days from the index procedure or randomization in to control arm for medical management patients to 1 year post procedure or randomization (Cohort B)
time frame: 1 year
Composite of survival, recurrent hospitalization and NYHA class.
time frame:

Eligibility Criteria

Male or female participants of any age.

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 ≥15% and/or a minimum STS score of 10 2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or 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%. Exclusion Criteria 1. Evidence of an acute myocardial infarction ≤ 1month 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, or severe (greater than 3+) mitral insufficiency 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 < 16mm or > 24mm 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 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 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

Additional Information

Official title THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
Principal investigator Martin B Leon, MD
Description Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.