Reprise III - Lotus Valve System in Percutaneous Replacement of Stenotic Aortic Valve

Condition/Intervention:

  • Aortic stenosis

Study Name:

REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Randomized Clinical Evaluation

Phase:

Phase 3

Summary:  

The study is designed to test the investigational use of the Lotus™ Valve System for transcatheter aortic valve replacement in patients with severe native aortic stenosis. Researchers will compare the effectiveness of the Lotus™ Valve System to the standard CoreValve™ Transcatheter Aortic Valve Replacement System.

The Lotus Valve System potentially provides a number of performance and safety features in its design, which includes the enhanced ability to place the study valve correctly at first attempt and the capacity to reposition or retrieve the study valve. The Lotus System also features a barrier between the native aortic valve and the study valve frame, which helps to reduce the leakage of blood.

Key Inclusion Criteria:

  • Documented calcific, severe native aortic stenosis
  • Aortic annulus size of ≥ 20 mm and ≤ 27 mm and is deemed treatable with an available size of both test and control device
  • Symptomatic aortic valve stenosis with New York Heart Association Functional Class ≥ II
  • Agreement by the heart team that subject is at high or extreme operative risk for surgical valve replacement

Key Exclusion Criteria:

  • Congenital unicuspid or bicuspid aortic valve
  • Acute myocardial infarction within 30 days prior to the procedure
  • Cerebrovascular accident or transient ischemic attack within the past 6 months prior to enrollment
  • Subject has a pre-existing prosthetic aortic or mitral valve.
  • Subject has severe aortic, tricuspid, or mitral regurgitation.

Please see additional list of inclusion and exclusion criteria.

Principal Investigator:

Raj Makkar, MD

Co-Investigators Include:

Wen Cheng, MD
Mamoo Nakamura, MD
Hasan Al-Jilaihawi, MD

Study Coordinator and Contact:

Mitch Gheorghiu
Phone: 310-423-6152
Email: mitch.gheorghiu@cshs.org

Status:

Active

IRB No.:

37606

Date Last Updated:

04/15