VisONE Heart Failure Study: Pilot

VisCardia

Status: Completed

Conditions: Heart Failure With Reduced Ejection Fraction, HFrEF

Treatments: Device: VisONE ADS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03484780

VisCardia H01_17

Details and patient eligibility

About

The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system for 12 months.

Full description

This 12 month study is intended to validate the early benefits observed with Asymptomatic Diaphragmatic Stimulation (ADS) as a primary form of heart failure therapy with low rates and severity of adverse effects. Medical refractory symptomatic heart failure patients with reduced ejection fraction and no evidence of arrhythmias or ventricular dysynchrony will undergo laparoscopic implantation of the VisONE™ implantable system comprised of a pulse generator and two leads, programmed to deliver cardiac-gaited diaphragmatic stimulation pulses at asymptomatic outputs. Patients will be followed in pre-specified durations of 1,3,6 and 12-months using a series of evaluations of hemodynamic, echocardiographic, heart failure status, diaphragmatic function, implanted system data and standard safety measures including adverse events, for comparison with their baseline values. The results are intended to be used for designing a subsequent larger study for performing statistical power calculations.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• NYHA class II/III medical refractory despite guideline indicated heart failure medications
• Sinus rhythm with <10% ectopy
• EF ≤ 35%
• NT-proBNP > 500 (250 if on loop diuretics)

Exclusion Criteria

• 6MHW >500 m or < 200 m
• Resting HR > 140 bpm
• SBP <80 mmHg or > 170 mmHg
• Serum creatine > 2.5 mg/dL
• Ventricular dyssynchrony by ECG with QRS ≥ 140ms
• Unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF, NSVT, sustained VT or VF, or DCCV within 3 months
• Intermittent inotropic drug treatment
• Existing pacemaker or indications for a pacemaker
• Severe primary pulmonary disease including pulmonary arterial hypertension or severe COPD, or other respiratory or lung diseases where FEV < 50% or any condition with severe diaphragmatic dysfunction
• Previous open laparotomy within 1 year or contraindications to laparoscopy, as determined by implanting physician
• Known or active intra-abdominal infections, or known intra-abdominal pathology
• Previous thoracic or abdominal organ transplant, transplant waiting list
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

VisONE ADS

Experimental group

Description:

Patients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation

Treatment:

Device: VisONE ADS