Fontan PhysiologyPhase 1FONTAN-CMRNCT03251742
Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients
A Phase 1 study testing Hayek RTX ventilator in people with Fontan Physiology, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fontan Physiology
- What is being tested?
- Hayek RTX ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2017to 1 May 2018
- Phase
- Phase 1
- 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 13 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Fontan patients age > 13 years.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital/University of Toronto.
Toronto, Ontario, M5G2N2
About this study
Official title: Feasibility and Efficacy Of Negative Pressure Ventilation in Fontan populatioN: Cardiovascular Flow Assessment by Magnetic Resonance Imaging
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.
- Conditions
- Fontan Physiology
- Being tested
- Hayek RTX ventilator
- Keywords
- Fontan operation, Negative pressure ventilation, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hayek RTX ventilatorDevice
Also called Cuirass, Negative pressure ventilation
Negative pressure ventilation in Fontan patients.
| Study group | Role | What they receive |
|---|---|---|
| Fontan patient population | Active comparator | Not described Receives: Device: Hayek RTX ventilator |
| Healthy volunteers | Sham comparator | Not described Receives: Device: Hayek RTX ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the NPV on cardiac output
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.
Measured: 6-8 months
Efficacy of the NPV on organ perfusion
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.
Measured: 6-8 months
Secondary outcomes (1)
Tolerability and safety of negative pressure ventilation.
Assessed by participant questionnaire rating tolerance, safety, overall satisfaction with the device.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start17 Nov 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fontan PhysiologyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hayek Medical
- Responsible party
- Principal investigator, Pradeepkumar Charla, University Health Network, Toronto
- Investigators
- Rachel Wald, MD, MS, Principal investigator, Toronto General Hospital/University Health NetworkPradeepkumar Charla, MD, MS, Study director, Toronto General Hospital/University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251742
- Sponsor's protocol ID
- Fontan0615
- Acronym
- FONTAN-CMR
- Status last verified
- May 2018
- First submitted
- 4 Apr 2017
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaji S, Zafar MA, Christopher A, Saraf A, Hoskoppal A, Lanford L, Kreutzer J, Olivieri L, Alsaied T. Augmented Biphasic Breathing Using Sniff and an Oral Positive Expiratory Pressure Device (Sniff-PEP) in Fontan Patients. Pediatr Cardiol. 2025 Aug;46(6):1725-1732. doi: 10.1007/s00246-024-03598-3. Epub 2024 Jul 19.
PubMed 39028352
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy Of Negative Pressure Ventilation in Fontan populatioN: Cardiovascular Flow Assessment by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03251742
- Acronym / sponsor ID
- FONTAN-CMR / Fontan0615
- Conditions
- Fontan Physiology
- Keywords
- Fontan operation, Negative pressure ventilation, MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Hayek Medical
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fontan patient population | Active comparator | Device: Hayek RTX ventilator |
| Healthy volunteers | Sham comparator | Device: Hayek RTX ventilator |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Fontan patients age > 13 years.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hayek RTX ventilatorAlso: Cuirass, Negative pressure ventilationNegative pressure ventilation in Fontan patients. | Device | Fontan patient population, Healthy volunteers |
Primary outcome
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.
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.
1 secondary outcome
Tolerability and safety of negative pressure ventilation.
Time frame: 6-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Derived from this study: PubMed 39028352Shaji S, Zafar MA, Christopher A, Saraf A, Hoskoppal A, Lanford L, Kreutzer J, Olivieri L, Alsaied T. Augmented Biphasic Breathing Using Sniff and an Oral Positive Expiratory Pressure Device (Sniff-PEP) in Fontan Patients. Pediatr Cardiol. 2025 Aug;46(6):1725-1732. doi: 10.1007/s00246-024-03598-3. Epub 2024 Jul 19.
- Individual participant dataSharing planned: No
Related trials for Fontan Physiology
Not yet recruitingObservational study
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
Fontan Procedure, Fontan Circulation
RecruitingPhase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Fontan Palliation
Recruiting
Venous Compression in Fontan
Single-ventricle, Fontan Circulation
RecruitingObservational study
Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.
Congenital Heart Surgery, Congenital Heart Disease in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Wald, MD, MS principal investigator
Toronto General Hospital/University Health Network
Pradeepkumar Charla, MD, MS study director
Toronto General Hospital/University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hayek RTX ventilator in people with Fontan Physiology, run by University Health Network, Toronto at 1 site in Canada.
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 1 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of the NPV on cardiac output (time frame: 6-8 months). The study lists 2 primary outcomes in all. 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 NCT03251742, which also lists 1 linked publication.
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 1 Jun 2018.