VisONE Heart Failure Study: Pilot | Clinical Trial

Key information

Conditions

Heart Failure With Reduced Ejection Fraction, HFrEF

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VisONE ADS

Device

VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation

Other names: Synchronized Diaphragmatic Stimulation

Primary outcomes

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

Time frame: after 3 months of 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 outcomes

Freedom from complications or adverse events during chronic therapy

Time frame: after 3 and 12 months of 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

Time frame: after 12 months of 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

Other outcomes

Clinical composite of heart failure and cardiac function

Time frame: after 0, 1, 3, 6 and 12 months of therapy
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

Sponsors and collaborators

Lead sponsor

VisCardia Inc.

Industry

Collaborators

Clinical Accelerator
Stiftung für Herz-und Kreislaufkrankheiten
University Hospital, Zürich
University of Glasgow

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Apr 2, 2018
Registry last updated: May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.