THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

Edwards Lifesciences

Status: Completed

Conditions: Critical Aortic Stenosis

Treatments: Other: medical management and/or balloon aortic valvuloplasty; Device: Edwards SAPIEN Transcatheter Heart Valve; Device: Surgical Valve Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530894

2006-06-US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,057 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,057 participants in 4 patient groups

1

Experimental group

Description:

Cohort A: Sapien Valve

Treatment:

Device: Edwards SAPIEN Transcatheter Heart Valve

2

Active Comparator group

Description:

Cohort A: other surgical valve

Treatment:

Device: Surgical Valve Replacement

3

Experimental group

Description:

Cohort B: Sapien Valve

Treatment:

Device: Edwards SAPIEN Transcatheter Heart Valve

4

Active Comparator group

Description:

Cohort B: Medical therapy

Treatment:

Other: medical management and/or balloon aortic valvuloplasty