Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-28 @ 3:46 PM
Study NCT ID:
NCT05592392
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RECOVER-HF Pilot Study of SDS in Heart Failure
Sponsor:
VisCardia Inc.
Organization:
Study Overview
Official Title:
RECOVER-HF Pilot Study - Randomized, Single-Center, Double-blinded Study of Synchronized Diaphragmatic Stimulation (SDS) for Improvement of Symptomatic Reduced Ejection Fraction Heart Failure
Status:
COMPLETED
Status Verified Date:
2025-09
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:
The RECOVER HF pilot is a feasibility study for evaluating a randomized, doubled-blinded study design to determine the benefits and risks of chronically delivering Synchronized Diaphragmatic Stimulation (SDS) in Heart Failure patients on GDMT with NYHA II/III, EF\<=40% and QRSd,=130ms.
Detailed Description:
Symptomatic Diaphragmatic Stimulation (SDS) is a novel approach designed to improve cardiac function, symptoms, and, ultimately, outcomes for patients who are symptomatic for 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 with a resultant reduction in pericardial restraint, leading to improved cardiac filling and reduced afterload. When applied at the right time in the cardiac cycle, SDS can improve cardiac filling, cardiovascular pressure conditions, and systolic cardiac performance.
Encouraged by the results of the VisONE HF study pilot (NCT03484780), SDS shall now be further valuated in a randomized controlled trial (RCT) pilot. This RCT pilot has three objectives: two semi-acute items (15-30 days) verification of sensing function using the modified input filters and improved usability based on increased automaticity of the user-interface; and one chronic result (6 months) to reproduce similar efficacy endpoints. The herein described study is a pilot trial for a larger RCT trial.
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 with a resultant reduction in pericardial restraint, leading to improved cardiac filling and reduced afterload. When applied at the right time in the cardiac cycle, SDS can improve cardiac filling, cardiovascular pressure conditions, and systolic cardiac performance.
Encouraged by the results of the VisONE HF study pilot (NCT03484780), SDS shall now be further valuated in a randomized controlled trial (RCT) pilot. This RCT pilot has three objectives: two semi-acute items (15-30 days) verification of sensing function using the modified input filters and improved usability based on increased automaticity of the user-interface; and one chronic result (6 months) to reproduce similar efficacy endpoints. The herein described study is a pilot trial for a larger RCT trial.
Study Oversight
Has Oversight DMC:
True
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?: