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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* NYHA classes II/III on optimal Guideline Directed Medical Therapy
* QRS duration ≤ 130 ms
* LVEF \< 40%
* Willing and able to comply with protocol requirements, including attending all required visits
* Wiling to participate in the study and able to sign an informed consent form
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
* Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT or DCCV within 3 months
* Intermittent IV inotropic drug treatment
* Arrhythmias present during screening (profound ectopy, bradycardia, profound prevalence of ectopy, NSVT, VF, AF\*, SVT or AFLT) - \* see enrollment exception allowing for 10 patients in AF for a separate subgroup analysis
* 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-abdomin…
What they're measuring
1
Change in LVESV
Timeframe: 6 months
2
Freedom from VisONE device-related and procedure-related Major Adverse Respiratory and Cardiovascular Events (MARCE) after the index implantation procedure