Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Alleviant Medical, Inc.
- Enrollment
- 350
- Locations
- 68
- Primary Endpoint
- Composite Primary Endpoint
Study Overview
Brief Summary
Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- LVEF ≤ 40%
- NYHA class II, III or ambulatory IV HF
- Receiving optimal, maximally tolerated, stable GDMT
Exclusion Criteria
- Advanced heart failure
- Life-expectancy < 12 months
- Evidence of right heart dysfunction
Arms & Interventions
Treatment
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
Intervention: Alleviant ALV1 System (Device)
Control
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
Intervention: Sham-Control (Other)
Outcomes
Primary Outcomes
Composite Primary Endpoint
Time Frame: 12-Month
The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (68)
Identifiers
- NCT ID
- NCT06812533
- Other Study IDs
- CIP-0006
Dates
- First Submitted
- (last year)
- First Posted
- (last year)
- Primary Completion
- (in 2 years)
- Study Completion
- (in 2 years)
- Last Verified
- (29 days ago)
- Last updated
- (14 days ago)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- Yes
- IPD Sharing Plan
- No
- Has Results
- No