A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement who have Severe, Calcific, Aortic Stenosis (PARTNER III).
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).
Key Inclusion Criteria:
1. 65 years of age or older at time of consent.
2. Symptomatic, severe, calcific aortic stenosis with the following TTE criteria:
Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND
AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
3. Aortic valve annulus 273 mm2 - 683 mm2 measured by 3D imaging (CT, TEE or MRI)
4. Adequate iliofemoral access with minimum average vessel diameter of 5.5mm (20, 23, 26mm) and 6.0mm (29mm) and acceptable level of vessel calcification and tortuosity for safe device implant
5. NYHA Functional Class ≥ II
6. Heart team agrees the patient has a risk of operative mortality < 2% (e.g., STS <4).
7. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
See clinicaltrials.gov for full details.
Heart and Vascular
Valvular Heart Disease
Robert Hodson MD
- Providence St. Vincent Medical Center