Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05839730
Status:
SUSPENDED
Last Update Posted:
2024-04-02
First Post:
2023-03-01
Brief Title:
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Status:
SUSPENDED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Revision of the protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRE-HFpEF
Brief Summary:
FIRE-HFpEF is a multi-center prospective randomized single-blinded clinical feasibility study This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects
Detailed Description:
After enrollment baseline data will be collected and subjects will then have a pacemaker implanted After 6 weeks subjects will have a follow up visit with a blood draw and a cardiac MRI At this visit subjects will be randomized 21 for pacing therapy or as a control programmed into either a non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest After 3 6 and 9 months after randomization subjects will return for a follow up visit At the 9-month visit therapy modifications will be made based on initial pacing randomization assignment pacing therapy will be terminated in the original therapy group and enabled in the control group After an additional 3-months of follow-up subjects will return for their final visit therapies will be disabled in all subjects and subjects will be exited Echocardiographic functional and health status endpoints will be collected and analyzed to assess therapy efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None