Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Device: Synchronized Diaphragmatic Stimulation
- Registration Number
- NCT06552637
- Lead Sponsor
- VisCardia Inc.
- 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 II/III, 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 1:1 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 U.S. These centers will enroll subjects with the goal of randomizing approximately 270 subjects who meet the entry criteria.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 270
- NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
- QRS duration ≤ 130 ms
- EF≤ 40%
- Baseline 6 minute walk test > 500 meters or < 200 meters
- NT-proBNP< 250 if on loop diuretics, or NT-proBNP < 500 if not on loop diuretics
- Supine resting heart rate > 140 bpm
- Systolic blood pressure < 80 mmHg or > 170 mmHg
- Serum creatinine > 2.5 mg/dL
- Serum hepatic function 3x ULN
- Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT or DCCV within 3 months
- Intermittent IV inotropic drug treatment
- Bradycardia (heart rate < 50 beats/min), atrial arrhythmias with rates > 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy >10% present during screening
- Significant uncontrolled symptomatic bradyarrhythmias, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy > 10% documented within the previous 3 months
- Reversible non-ischemic cardiomyopathy
- Primary valvular disease
- Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys >70 mmHg at rest
- Severe COPD, other respiratory or lung diseases where FEV < 50%
- Pericardial disease
- Diabetic neuropathy
- Existing diaphragmatic stimulation for respiration assist
- LVAD or other mechanical cardiac assist devices
- Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician
- Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.
- Previous open laparotomy within 1 year
- Previous thoracic or abdominal organ transplant
- Drug induced immuno-suppression
- Body mass index > 40
- Enrollment in a concurrent investigation / clinical study
- Having a life expectancy of <1 year due to any condition
- Pregnant or planning a pregnancy during the study period
- Known allergies to implantable device materials
- Recent history of systemic infections
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device and Medical Management Synchronized Diaphragmatic Stimulation * Subjects will be implanted with the VisONE System programmed to deliver SDS (Therapy On) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Device: VisONE System (SDS) * Drug: Medical Management Medical Management Synchronized Diaphragmatic Stimulation * Subjects will be implanted with the VisONE System programmed not to deliver SDS (Therapy Off) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Drug: Medical Management
- Primary Outcome Measures
Name Time Method Six Minute Hall Walk (6MHW) 6 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 6 months post-randomization from baseline than medical management alone.
Left ventricular End-Systolic Volume (LVESV) 6 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 6 months post-randomization from baseline than medical management alone.
Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL) 6 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 6 months post-randomization from baseline than medical management alone.
Major Adverse Respiratory and Cardiovascular Events (MARCE) 6 months To demonstrate the safety of the VisONE System by analyzing Major Adverse Respiratory and Cardiovascular Events (MARCE) occurring within 6 months post implant for the rate, severity and association with the device or procedure (goal \>70% freedom):
* Cardiovascular Death
* Stroke
* Cardiac Arrest
* Interaction with cardiac rhythm device requiring permanent termination of SDS therapy
* Acute Heart Failure Decompensation
* Infection requiring device/lead explant
* Diaphragmatic dysfunction leading to a clinically significant reduction is respiratory function
* Inadequate SDS therapy delivery requiring surgical intervention
* Injury to abdominal organs requiring surgical intervention
* Pneumothorax
* Hemothorax
- Secondary Outcome Measures
Name Time Method N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP) 12 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 12 months post-randomization from baseline than medical management alone.
Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL) 12 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in MLWHF QOL at 12 months post-randomization from baseline than medical management alone.
Left Ventricular Ejection Fraction (LVEF) 12 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 12 months post-randomization from baseline than medical management alone.
Six Minute Hall Walk (6MHW) 12 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in 6MHW at 12 months post-randomization from baseline than medical management alone.
Left ventricular End-Systolic Volume (LVESV) 12 months To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger percent improvement in LVESV at 12 months post-randomization from baseline than medical management alone.