Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
Steven Bailey
(210) 567-4601
baileys@uthscsa.edu
Joan Hecht
(210) 617-5300
hecht@uthscsa.edu
Monique Johnson
JohnsonM13@uthscsa.edu
Principal Investigator
Steven Bailey
Steven Bailey
(210) 567-4601
baileys@uthscsa.edu
Monique Johnson
JohnsonM13@uthscsa.edu
Johnnie Jones
(210) 450-7277
jonesj21@uthscsa.edu
Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
SELECT EXCLU
Advanced heart failure defined as one or more of the below:
Presence of significant valve disease defined by the site cardiologist as:
Arm | Description | Intervention |
---|---|---|
Control | Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium. | intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium. |
Treatment | Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure. | The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure. |