Status:
COMPLETED
Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Hayek Medical
Conditions:
Fontan Physiology
Eligibility:
All Genders
13-55 years
Phase:
PHASE1
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 di...
Eligibility Criteria
Inclusion
- Fontan patients age \> 13 years.
Exclusion
- 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.
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03251742
Start Date
November 17 2017
End Date
May 1 2018
Last Update
June 1 2018
Active Locations (1)
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1
Toronto General Hospital/University of Toronto.
Toronto, Ontario, Canada, M5G2N2