Clinical trial NCT03484780: VisONE Heart Failure Study: Pilot
Official title: VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction, HFrEF
Keywords: Implantable Heart Failure Device Therapy
Asymptomatic Diaphragmatic Stimulation
Lead sponsor: VisCardia Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinical Accelerator
name: University of Glasgow
name: University Hospital, Zürich
name: Stiftung für Herz-und Kreislaufkrankheiten
First posted: 2018-04-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients implanted with the VisONE implantable system for delivering chronic Asymptomatic Diaphragmatic Stimulation (ADS).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Freedom from serious complications or adverse events during procedural recovery and acute therapy
timeFrame: after 3 months of therapy
Secondary outcomes:
measure: Freedom from complications or adverse events during chronic therapy
timeFrame: after 3 and 12 months of therapy
measure: Freedom from serious complications or adverse events during chronic therapy
timeFrame: after 12 months of therapy
Other outcomes:
measure: Clinical composite of heart failure and cardiac function
timeFrame: after 0, 1, 3, 6 and 12 months of therapy
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
city: Kiev
country: Ukraine
facility: Kyiv City Heart Center
city: Kyiv
country: Ukraine
facility: Amosov National Institute of Cardiovascular Surgery
Study officials:
affiliation: Kyiv City Heart Center
name: Vitaly Demyanchuk, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amosov National Institute of Cardiovascular Surgery
name: Rudenko Vladimirovich, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tbilisi Heart and Vascular Clinic
name: Tamaz Shaburishvil, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6.
citation: Roos M, Kobza R, Jamshidi P, Bauer P, Resink T, Schlaepfer R, Stulz P, Zuber M, Erne P. Improved cardiac performance through pacing-induced diaphragmatic stimulation: a novel electrophysiological approach in heart failure management? Europace. 2009 Feb;11(2):191-9. doi: 10.1093/europace/eun377.
citation: Jorbenadze A, Shaburishvili N, Mirro M, Zuber M, Erne P, Shaburishvili T. First-In-Human Visone Heart Failure Study: Asymptomatic Diaphragmatic Stimulation For Chronic Heart Failure With Reduced Ejection Fraction: Case Report. Journal of the American College of Cardiology. 2020;75(11) Supplement 1