Alleviant ALLAY-HFrEF Study | NCT06812533 | Trialant

Alleviant ALLAY-HFrEF Study | NCT06812533 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.	Device: Alleviant ALV1 System
Control	Sham Comparator	Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.	Other: Sham-Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite Primary Endpoint	The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.	12-Month

Contacts/Locations Module