Could a diaphragm pacemaker help failing hearts?
NCT ID NCT06552637
First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This study tests a device that stimulates the diaphragm in time with the heartbeat to help people with heart failure. Researchers will see if it improves heart function, exercise ability, and quality of life. About 270 participants will receive the device plus standard care, or standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Synchronized Diaphragmatic Stimulation device (VisONE System)
- What this could lead to
- If it works, this could offer a new treatment option for people with heart failure, potentially improving heart function, exercise ability, and quality of life.
- What could go wrong
- This is an early-stage trial with 270 participants, so results may not apply to everyone. The device requires surgery and carries risks like infection, breathing problems, or heart complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) * QRS duration ≤ 130 ms * EF≤ 40% Exclusion Criteria: * 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 * Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF (\> 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: 1. Greater than mild mitral valve stenosis 2. Greater than moderate mitral valve regurgitation 3. Greater than mild tricuspid valve stenosis 4. Greater than moderate-severe tricuspid valve regurgitation 5. Greater than moderate aortic stenosis 6. Greater than moderate aortic regurgitation 7. Greater than mild-moderate pulmonic stenosis 8. 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 FEV \< 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 * Diabetic neuropathy * 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); or CRT that is indicated or implanted and functional * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Saint Francis Hospital
RECRUITINGTulsa, Oklahoma, 74136, United States
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Tbilisi Heart and Vascular Clinic
RECRUITINGTbilisi, 0159, Georgia
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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