Pima Heart and Vascular | Research Office Tucson
Status
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
NYHA Class II, III or ambulatory IV
Exercise right heart catheterization*
Ongoing stable GDMT
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
500 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal