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New treatment option for Heart Failure With Reduced Ejection Fraction
Official title Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
ClinicalTrials.gov ID: NCT06552637
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
- QRS duration ≤ 130 ms
- EF≤ 40%
You likely can't join if
- 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 \ 170 mmHg
- Serum creatinine \> 2.5 mg/dL
- Serum hepatic function 3x ULN
See the full eligibility criteria
- 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 \ 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 \ 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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.