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Heart Failure With Reduced Ejection Fraction, HFrEFNCT03484780

VisONE Heart Failure Study: Pilot

A study testing VisONE ADS in people with Heart Failure With Reduced Ejection Fraction, HFrEF, run by VisCardia Inc. at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VisONE ADS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesin 2 countries
Study dates
25 Jul 2018to 12 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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 locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Ukraine2 sites

  • Kyiv City Heart Center

    Kiev

  • Amosov National Institute of Cardiovascular Surgery

    Kyiv

Other trials in Ukraine

Georgia1 site

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, 0159

Other trials in Georgia

About this study

Official title: VisONE Pilot Study of Chronic Asymptomatic Diaphragmatic Stimulation for Patients With Symptomatic Heart Failure, Reduced Ejection Fraction and Preserved Ventricular Synchrony

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.

Read the 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.

Being tested
VisONE ADS
Keywords
Implantable Heart Failure Device Therapy, Asymptomatic Diaphragmatic Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VisONE ADSDevice

    Also called Synchronized Diaphragmatic Stimulation

    VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation

Study groups in NCT03484780
Study groupRoleWhat they receive
VisONE ADSExperimentalPatients implanted with a VisONE stimulator and leads for receiving continual Synchronized Diaphragmatic Stimulation
Receives: Device: VisONE ADS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: after 3 months of therapy

Secondary outcomes (2)

  1. 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

    Measured: after 3 and 12 months of therapy

  2. 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

    Measured: after 12 months of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2018
  2. Study start25 Jul 2018
  3. Primary completion12 Dec 2019
  4. Study completion12 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients implanted with the VisONE implantable system for delivering chronic Asymptomatic Diaphragmatic Stimulation (ADS).
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484780
Sponsor's protocol ID
VisCardia H01_17
Status last verified
May 2020
First submitted
16 Mar 2018
Last updated
20 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24464736

  • 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.

    PubMed 19168496

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing VisONE ADS in people with Heart Failure With Reduced Ejection Fraction, HFrEF, run by VisCardia Inc. at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ukraine, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from serious complications or adverse events during procedural recovery and acute therapy (time frame: after 3 months of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03484780, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.

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