Ignite Creation Date:
2024-05-05 @ 9:44 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00957073
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2009-08-10
Brief Title:
Rheos System for the Treatment of HFpEF Heart Failure
Sponsor:
CVRx Inc
Organization:
CVRx Inc
Study Overview
Official Title:
Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction EF 40
Status:
COMPLETED
Status Verified Date:
2021-04
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:
HOPE4HF
Brief Summary:
The purpose of this clinical investigation NCT00957073 is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial utilizing the BAROSTIM NEO LEGACY device for Implantable Pulse Generator IPG replacements
Detailed Description:
The initial trial design randomized subjects in a 21 ratio to receive a Rheos system plus medical management Device Arm or to receive medical management alone Medical Management Arm On March 24 2011 the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed 19 subjects had been randomized 10 device and 9 medical management Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up 8 of the 10 device subjects continued in the study Long-term follow-up visits occurred at 15 and 18 months post-randomization visits occur semi-annually until study closure
The study was not stopped for safety or futility but for businessstrategic reasons due to production of a new generation of the device
The study was not stopped for safety or futility but for businessstrategic reasons due to production of a new generation of the device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None