Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552637
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RECOVER-HF - RandomizEd Multi-Center Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation SDS for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVER-HF
Brief Summary:
RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure
Detailed Description:
Symptomatic Diaphragmatic Stimulation SDS is a novel extra-cardiac device for patients who have symptomatic heart failure Elevated intracardiac pressures are the hallmark of heart failure HF and a key pathological driver of disease progression and limited exertional capacity The degree of cardiac pressure elevation is determined by preload afterload and pericardial restraint The pericardium restrains the heart and the degree of restraint is determined by the pericardial structure itself and the intrathoracic pressure This aspect of HF pathophysiology is among the fundamental drivers behind the SDS therapy concept SDS induces a temporal modulation of intrathoracic pressure When synchronized with the cardiac cycle SDS may improve cardiac filling cardiovascular pressure conditions and cardiac performance
RECOVER HF is a prospective randomized doubled-blinded study of Synchronized Diaphragmatic Stimulation SDS delivered in an imperceptible manner in subjects with heart failure defined as New York Heart Association NYHA functional class IIIII left-ventricular ejection fraction LVEF 40 and QRS duration 130ms despite receiving the appropriate heart failure guideline directed medical therapy GDMT All subjects will receive an implanted VisONE System Two-weeks post implant subjects will be randomized in a 11 ratio into a SDS therapy active or control SDS therapy inactive arm with both arms receiving GDMT At 6 months the control arm will have SDS therapy activated with all patients receiving therapy and GDMT throughout the remainder of the study period The study will be conducted at up to 30 investigational sites in the United States and several outside the US These centers will enroll subjects with the goal of randomizing approximately 270 subjects who meet the entry criteria
RECOVER HF is a prospective randomized doubled-blinded study of Synchronized Diaphragmatic Stimulation SDS delivered in an imperceptible manner in subjects with heart failure defined as New York Heart Association NYHA functional class IIIII left-ventricular ejection fraction LVEF 40 and QRS duration 130ms despite receiving the appropriate heart failure guideline directed medical therapy GDMT All subjects will receive an implanted VisONE System Two-weeks post implant subjects will be randomized in a 11 ratio into a SDS therapy active or control SDS therapy inactive arm with both arms receiving GDMT At 6 months the control arm will have SDS therapy activated with all patients receiving therapy and GDMT throughout the remainder of the study period The study will be conducted at up to 30 investigational sites in the United States and several outside the US These centers will enroll subjects with the goal of randomizing approximately 270 subjects who meet the entry criteria
Study Oversight
Has Oversight DMC:
None
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?:
None