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VisONE Heart Failure Study: Pilot

Primary Purpose

Heart Failure With Reduced Ejection Fraction, HFrEF

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VisONE ADS
Sponsored by
VisCardia Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction, HFrEF focused on measuring Implantable Heart Failure Device Therapy, Asymptomatic Diaphragmatic Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tbilisi Heart and Vascular Clinic
  • Kyiv City Heart Center
  • Amosov National Institute of Cardiovascular Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VisONE ADS

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Freedom from complications or adverse events during chronic therapy
The following adverse events will be analyzed for their rate and severity and compared to other implantable device systems Procedural or implanted system events resulting in adverse patient symptoms Degradation of respiratory function by spirometer measures associated with procedure or implanted system Adverse events due to procedural or implanted system complications correctable by non re-operative means including system reprogramming or other readjustments
Freedom from serious complications or adverse events during chronic 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

Full Information

First Posted
March 16, 2018
Last Updated
May 18, 2020
Sponsor
VisCardia Inc.
Collaborators
Clinical Accelerator Ltd., University of Glasgow, University Hospital, Zürich, Stiftung für Herz-und Kreislaufkrankheiten
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1. Study Identification

Unique Protocol Identification Number
NCT03484780
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisCardia Inc.
Collaborators
Clinical Accelerator Ltd., University of Glasgow, University Hospital, Zürich, Stiftung für Herz-und Kreislaufkrankheiten

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, HFrEF
Keywords
Implantable Heart Failure Device Therapy, Asymptomatic Diaphragmatic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients implanted with the VisONE implantable system for delivering chronic Asymptomatic Diaphragmatic Stimulation (ADS).
Masking
None (Open Label)
Masking Description
Independent data review and analysis by the University of Glasgow Department of Biostatistics
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VisONE ADS
Arm Type
Experimental
Arm Description
Patients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation
Intervention Type
Device
Intervention Name(s)
VisONE ADS
Other Intervention Name(s)
Synchronized Diaphragmatic Stimulation
Intervention Description
VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation
Primary Outcome Measure Information:
Title
Freedom from serious complications or adverse events during procedural recovery and acute therapy
Description
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
Time Frame
after 3 months of therapy
Secondary Outcome Measure Information:
Title
Freedom from complications or adverse events during chronic therapy
Description
The following adverse events will be analyzed for their rate and severity and compared to other implantable device systems Procedural or implanted system events resulting in adverse patient symptoms Degradation of respiratory function by spirometer measures associated with procedure or implanted system Adverse events due to procedural or implanted system complications correctable by non re-operative means including system reprogramming or other readjustments
Time Frame
after 3 and 12 months of therapy
Title
Freedom from serious complications or adverse events during chronic therapy
Description
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
Time Frame
after 12 months of therapy
Other Pre-specified Outcome Measures:
Title
Clinical composite of heart failure and cardiac function
Description
The following outcomes will be analyzed determine the potential therapeutic impact on clinical heart failure management NT Pro-BNP blood levels to assess heart failure status Improvements to cardiac output, stroke volume or left ventricular filling Improvements to left ventricular volumes or ejection fraction Improvements to heart failure status, 6 minute hall walk, or assessment by heart failure questionnaire
Time Frame
after 0, 1, 3, 6 and 12 months of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitaly Demyanchuk, M.D. Ph.D.
Organizational Affiliation
Kyiv City Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rudenko Vladimirovich, M.D.
Organizational Affiliation
Amosov National Institute of Cardiovascular Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamaz Shaburishvil, M.D.
Organizational Affiliation
Tbilisi Heart and Vascular Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Kyiv City Heart Center
City
Kiev
Country
Ukraine
Facility Name
Amosov National Institute of Cardiovascular Surgery
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24464736
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.
Results Reference
result
PubMed Identifier
19168496
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.
Results Reference
result
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
Results Reference
result
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT00769678
Description
Proof of concept therapeutic feasibility study of chronic ADS in post CABG heart failure patients

Learn more about this trial

VisONE Heart Failure Study: Pilot

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