Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583527
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2020-09-09
Brief Title:
Alleviate-HF-1 Study
Sponsor:
Alleviant Medical Inc
Organization:
Alleviant Medical Inc
Study Overview
Official Title:
Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with heart failure and preserved left ventricular ejection fraction HFpEF EF 50 or mid-range left ventricular ejection fraction HFmrEF 40 EF 50 with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical echocardiographic and invasive hemodynamic data
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None