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Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients (FONTAN-CMR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03251742
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
Hayek Medical
Information provided by (Responsible Party):
Pradeepkumar Charla, University Health Network, Toronto

Brief Summary:

The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers (ventricles) to allow blood flow within two distinct circuits: "pulmonary" and "systemic". The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic circuit delivers oxygen-rich blood throughout the body. In children born with a single ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen levels in the blood delivered to the body (cyanosis).

The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made connection (whereby two large body veins [cavae] are sewn to the pulmonary arteries), thereby preventing mixing of blood through restoration of two distinct circuits without mixing of blood. Although the Fontan operation effectively eliminates cyanosis and enables survival into adulthood, increased systemic venous pressure is an unavoidable systemic complication and low cardiac output (CO) is pervasive finding.

Despite excellent pediatric surgical results, the risk of late complications and death dramatically increases in the decades following Fontan surgery. A chronically low CO state secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction and shortened life expectancy. Short of heart transplantation, deemed suitable only for a minority of patients, effective therapies for low CO are largely absent. The investigators aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO. Specifically, external suction is applied intermittently to the chest wall, much like a vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass® ventilator (Hayek Medical). Although used in patients with lung disease, the investigators' proposal is to evaluate this novel, portable, ventilation system would be the first study of its kind in adults with congenital heart disease, specifically those with a Fontan palliation.


Condition or disease Intervention/treatment Phase
Fontan Physiology Device: Hayek RTX ventilator Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a cross-sectional study designed to evaluate the immediate impact of negative pressure ventilation (NPV) in an ambulatory Fontan population using cardiovascular magnetic resonance imaging (CMR) for assessment of cardiovascular flows.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Efficacy Of Negative Pressure Ventilation in Fontan populatioN: Cardiovascular Flow Assessment by Magnetic Resonance Imaging
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Arm Intervention/treatment
Active Comparator: Fontan patient population Device: Hayek RTX ventilator
Negative pressure ventilation in Fontan patients.
Other Names:
  • Cuirass
  • Negative pressure ventilation

Sham Comparator: Healthy volunteers Device: Hayek RTX ventilator
Negative pressure ventilation in Fontan patients.
Other Names:
  • Cuirass
  • Negative pressure ventilation




Primary Outcome Measures :
  1. Efficacy of the NPV on cardiac output [ Time Frame: 6-8 months ]
    Cardiac output will be measured in L/min/m2 using phase contrast MRI. Flow measurements will be made at baseline and with application of the device.

  2. Efficacy of the NPV on organ perfusion [ Time Frame: 6-8 months ]
    Multi organ perfusion will be measured in L/min/m2 using phase contrast MRI. Flow measurements will be made at baseline and with application of the device.


Secondary Outcome Measures :
  1. Tolerability and safety of negative pressure ventilation. [ Time Frame: 6-8 months ]
    Assessed by participant questionnaire rating tolerance, safety, overall satisfaction with the device.



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Ages Eligible for Study:   13 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fontan patients age > 13 years.

Exclusion Criteria:

  • unable to complete MRI (pacemaker/defibrillator/retained wires, pregnancy, claustrophobia);
  • evidence of Fontan failure (requiring ongoing medical / device therapy) protein-losing enteropathy, intracardiac thrombus, anatomical obstruction to the Fontan circuit;
  • patent Fontan fenestration;
  • oxygen saturation < 90%;
  • ongoing arrhythmia;
  • ejection fraction < 50% on echocardiography or CMR;
  • moderate or severe valve insufficiency on echocardiography or CMR;
  • Obesity (BMI >35);
  • severe obstructive sleep apnea (AHI>20);
  • chronic obstructive lung disease (FEV1/FVC<60%);
  • severe chest wall deformities (scoliosis, kyphosis, kyphoscoliosis);
  • acute or chronic kidney disease (eGFR<60)
  • unable to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251742


Locations
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Canada, Ontario
Toronto General Hospital/University of Toronto.
Toronto, Ontario, Canada, M5G2N2
Sponsors and Collaborators
University Health Network, Toronto
Hayek Medical
Investigators
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Principal Investigator: Rachel Wald, MD, MS Toronto General Hospital/University Health Network
Study Director: Pradeepkumar Charla, MD, MS Toronto General Hospital/University Health Network

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Responsible Party: Pradeepkumar Charla, Clinical Fellow, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03251742    
Other Study ID Numbers: Fontan0615
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pradeepkumar Charla, University Health Network, Toronto:
Fontan operation
Negative pressure ventilation
MRI