VisONE Heart Failure Study: Pilot

NCT03484780 | Completed DMC

• 1 other identifier: VisCardia H01_17
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 3

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.

Conditions

Heart Failure With Reduced Ejection Fraction, HFrEF

Keywords

Implantable Heart Failure Device Therapy; Asymptomatic Diaphragmatic Stimulation

Outcome Measures

Primary Outcomes (1)

• Freedom from serious complications or adverse events during procedural recovery and acute therapy

  The following serious complications and adverse events will be analyzed for their rate and severity and compared to other implantable device systems * Excessive procedural or implanted system morbidity * Procedural or implanted system events resulting in unscheduled patient hospitalizations and surgical intervention * Incidences resulting in physician choice to permanently discontinue therapy

  after 3 months of therapy

Secondary Outcomes (2)

• Freedom from complications or adverse events during chronic therapy

  after 3 and 12 months of therapy

• Freedom from serious complications or adverse events during chronic therapy

  after 12 months of therapy

Other Outcomes (1)

• Clinical composite of heart failure and cardiac function

  after 0, 1, 3, 6 and 12 months of therapy

Study Arms (1)

VisONE ADS

EXPERIMENTAL

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

Device: VisONE ADS

Interventions

VisONE ADS DEVICE

VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation

Also known as: Synchronized Diaphragmatic Stimulation

VisONE ADS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• MHW \>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

Sponsors & Collaborators

• VisCardia Inc.: lead
• Clinical Accelerator: collaborator
• University of Glasgow: collaborator
• University Hospital, Zürich: collaborator
• Stiftung für Herz-und Kreislaufkrankheiten: collaborator

Study Sites (3)

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Location

Kyiv City Heart Center

Kiev, Ukraine

Location

Amosov National Institute of Cardiovascular Surgery

Kyiv, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 24464736 RESULT

• 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.

  PMID: 19168496 RESULT

• 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

  RESULT

Related Links

• Proof of concept therapeutic feasibility study of chronic ADS in post CABG heart failure patients

Study Officials

• Vitaly Demyanchuk, M.D. Ph.D.

  Kyiv City Heart Center

  PRINCIPAL INVESTIGATOR

• Rudenko Vladimirovich, M.D.

  Amosov National Institute of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

• Tamaz Shaburishvil, M.D.

  Tbilisi Heart and Vascular Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Independent data review and analysis by the University of Glasgow Department of Biostatistics
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients implanted with the VisONE implantable system for delivering chronic Asymptomatic Diaphragmatic Stimulation (ADS).

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: April 2, 2018
• Study Start: July 25, 2018
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2); GE (1)