Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure
Sujal Modi
Primary Investigator
Brief description of study
What is the purpose of this study?
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
Detailed description of study
What will happen during the study?
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.
Experimental: Treatment
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
Creation of interatrial shunt
Sham Comparator: Control
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Heart Failure
-
Age: 40 years - 100 years
-
Gender: All
Inclusion Criteria:
- Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- NYHA Class II, III or ambulatory IV
- Exercise right heart catheterization*
- Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- Exercise PVR < 1.8 WU
- Ongoing stable GDMT
Exclusion Criteria:
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
