Heart Failure With Reduced Ejection FractionRECOVER-HFNCT06552637
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
A study testing Synchronized Diaphragmatic Stimulation in people with Heart Failure With Reduced Ejection Fraction, run by VisCardia Inc. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Synchronized Diaphragmatic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Jul 2026to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) for 3 months
- EF≤ 40%
- At the time of consent, willing and able to comply with protocol requirements, including attending all required visits
- Willing to participate in the study and able to sign an informed consent form
- ≥18 years of age at the time of consent
Who cannot join
- 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
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- Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, AF (episodes > 24 hours), symptomatic NSVT or DCCV
- Any inotropic drug treatment within the previous 3 months
- 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 bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy > 10% documented within the previous 3 months
- Reversible non-ischemic cardiomyopathy
- Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:
- Greater than mild mitral valve stenosis
- Greater than moderate mitral valve regurgitation
- Greater than mild tricuspid valve stenosis
- Greater than moderate-severe tricuspid valve regurgitation
- Greater than moderate aortic stenosis
- Greater than moderate aortic regurgitation
- Greater than mild-moderate pulmonic stenosis
- Greater than moderate pulmonic regurgitation
- Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys >70 mmHg at rest
- Severe COPD, other respiratory or lung diseases where FEV1 < 50%
- Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months
- Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray
- Pericardial disease
- Non-cardiac condition substantially impairing ambulation of 6-minute hall walk test interpretation
- Existing diaphragmatic stimulation for respiration assist
- Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months)
- 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
- History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months
- Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT
- Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Ajith Nair, MD, (713) 798-6230, ajith.nair@bcm.edu
Ajith Nair, MD
- Recruiting
Ascension St. Vincent Hospital
Indianapolis, Indiana, 46260
Sangita Sudharshan, (317) 338-6666, sangita.sudharshan@ascension.org
Sangita Sudharshan, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Aditya Parikh, MD, (215) 615-4949
Aditya Parikh, MD
- Recruiting
Saint Francis Hospital
Tulsa, Oklahoma, 74136
Ralph D Ensley, MD, (918) 494-8500
Ralph D Ensley, MD
Georgia1 site, 1 recruiting
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159
Tamaz Shaburishvili, MD, 0322 157 159
Tamaz Shaburishvili, MD
About this study
Official title: RECOVER-HF - RandomizEd, Multi-Center, Double-Blinded Study of SynchrOnized Diaphragmatic Stimulation (SDS) for ImproVEment of Symptomatic Reduced Ejection Fraction Heart Failure
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.
Read the 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.
- Being tested
- Synchronized Diaphragmatic Stimulation
- Keywords
- Heart Failure, Heart Disease, Synchronized Diaphragmatic Stimulation, Implantable Heart Failure Device Therapy
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synchronized Diaphragmatic StimulationDevice
Also called Asymptomatic Diaphragmatic Stimulation, SDS, ADS, VisONE SDS
Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.
| Study group | Role | What they receive |
|---|---|---|
| Device and Medical Management | Experimental | * 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 Receives: Device: Synchronized Diaphragmatic Stimulation |
| Medical Management | Sham comparator | * 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 Receives: Device: Synchronized Diaphragmatic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular End-Systolic Volume (LVESV)
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.
Measured: 6 months
Six Minute Hall Walk (6MHW)
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.
Measured: 6 months
Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
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.
Measured: 6 months
Major Adverse Respiratory and Cardiovascular Events (MARCE)
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
Measured: 6 months
Secondary outcomes (7)
Left Ventricular Ejection Fraction (LVEF)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger improvement in LVEF at 6 months post-randomization from baseline than medical management alone.
Measured: 6 months
N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
To demonstrate that treatment with the VisONE System (SDS) plus GDMT results in a larger reduction in NT-proBNP (log-10 transformed) at 6 months post-randomization from baseline than medical management alone.
Measured: 6 months
Left ventricular End-Systolic Volume (LVESV)
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.
Measured: 12 months
Six Minute Hall Walk (6MHW)
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.
Measured: 12 months
Minnesota Living with Heart Failure quality of Life Score (MLWHF QOL)
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.
Measured: 12 months
Left Ventricular Ejection Fraction (LVEF)
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.
Measured: 12 months
N-Terminal Pro Brain Natriuretic Peptide (NT-proBNP)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start8 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Initial randomization into Control and Therapy arms for 6 month primary endpoints, afterwards crossover of Control arm into Therapy arm for 12 month secondary endpoints.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VisCardia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Accelerator, Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Lee R Goldberg, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552637
- Sponsor's protocol ID
- VisCardia H03_22
- Acronym
- RECOVER-HF
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes