Alleviant ALLAY-HF Study | NCT05685303 | Trialant

Alleviant ALLAY-HF Study | NCT05685303 | 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 mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.	12-month

Contacts/Locations Module