Our proposed study will evaluate the effect of temporary mechanical occlusion of the superior vena cava using a commercially available percutaneously deployed catheter-mounted balloon in patients with HFrEF receiving support with the Impella CP or 5.5 transvalvular flow pumps. Specifically, we aim to identify whether transient superior vena cava occlusion during transvalvular flow pump use can rapidly reduce cardiac filling pressures and allow for left ventricular unloading at lower transvalvular flow pump speeds.
Preload Regulation by Superior Vena Cava Occlusion in Patients Receiving Impella CP
Preload Regulation by Superior Vena Cava Occlusion in Patients Receiving Impella CP
Heart failure
All genders
18-80
Recruiting now
Overview
Principal Investigator: Carey Kimmelstiel, MD
Contact Us
Jamie Rubinstein / Peter Zazzali (Peter.Zazzali@tuftsmedicine.org)
Study details
Inclusion Criteria
- Patients between 18 and 80 years of age.
- AHA Stage C or Stage D HFrEF, with most recent echocardiogram demonstrating a LV ejection fraction of <40%
- Referred to the Tufts Medical Center Cardiac Catheterization Laboratory for planned elective high-risk PCI requiring hemodynamic support with an Impella CP.
Exclusion Criteria
- Patient unable to provide consent
- Patient unable to tolerate a cardiac catheterization procedure
- Patient supported currently with another mechanical circulatory support device
Study Requirements
The research-related activities will be completed prior to start of the high-risk PCI procedure. Upon completion of the experimental protocol and data collection, the Coda balloon catheter and LV pigtail catheter will be removed. No follow up visits, blood draws, or imaging required for trial.