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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
35
Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.
Tbilisi Heart And Vascular Clinic
Tbilisi, Georgia
Republican Specialized Scientific and Practical Medical Center for Surgery n.a. V. Vakhidov
Tashkent, Uzbekistan
Change in LVESV
Change from baseline in left ventricular end systolic volume (LVESV) post-randomization between the control group and the therapy group.
Time frame: 6 months
Freedom from VisONE device-related and procedure-related Major Adverse Respiratory and Cardiovascular Events (MARCE) after the index implantation procedure
The following Major Respiratory and Cardiovascular Events will be analyzed for their rate and severity and association with the implantable device or procedure: 1. CV Death 2. Stroke 3. Cardiac Arrest 4. Interaction with cardiac rhythm device requiring permanent termination of SDS therapy 5. Acute Heart Failure Decompensation 6. Infection requiring device/lead explant 7. Diaphragmatic dysfunction leading to a clinically significant reduction is respiratory function 8. Inadequate SDS therapy delivery requiring surgical intervention 9. Injury to abdominal organs requiring surgical intervention 10. Pneumothorax 11. Hemothorax 12. Peritonitis
Time frame: 12 months
Change in 6MHW distance
Change from baseline in 6 MHW distance post-randomization between the control group and the therapy group.
Time frame: 6 months
Change in MLWHF overall score
Change from baseline in MLWHF total score post-randomization between the control group and the therapy group.
Time frame: 6 months
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