Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-27 @ 9:35 AM
Study NCT ID:
NCT02600234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-10
First Post:
2015-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REDUCE LAP-HF RANDOMIZED TRIAL I
Sponsor:
Corvia Medical
Organization:
Study Overview
Official Title:
REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-06
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:
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
Detailed Description:
The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction \>40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: