Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICEAlleviant ALV1 System
Creation of interatrial shunt
OTHERSham-Control
Cardiac imaging
Sponsors
Alleviant Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40% 2. NYHA Class II, III or ambulatory IV 3. Exercise right heart catheterization\* 1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg) 2. Exercise PVR \< 1.8 WU 4. Ongoing stable GDMT
Exclusion criteria
1. Advanced heart failure 2. Presence of a pacemaker 3. Evidence of right heart dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Primary Endpoint | 12-month | 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. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Georgia, Germany, Israel, Italy, New Zealand, Poland, Spain, United States
Contacts
CONTACTJennifer Olson
PRINCIPAL_INVESTIGATORJames Udelson, MD
Tufts Medical Center
Outcome results
None listed