Congenital Heart DiseasesNISQICNCT03437148
Non-Invasive Shunt Quantification in Interatrial Communication
A study testing Innocor® and Physioflow® in people with Congenital Heart Diseases and Hemodynamic, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Shunt quantification in atrial septal defect (ASD) is estimated by Echocardiography-Doppler, with the pulmonary-to-systemic blood flow ratio: Qp/Qs. Higher is the ratio, more important is the shunt, and the consequence on right ventricular function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Diseases, Hemodynamic, Cardiac Output
- What is being tested?
- Innocor® and Physioflow®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2018to 3 Oct 2022
- 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
- cooperate patients over 18 years, having a OS ASD with an indication of interventional closure according to the European Cardiology society guidelines of 2010.
- Patients with significant shunt (signs of right ventricular volume overload) and Pulmonary Vascular Resistance (PVR) <5WU
- ASD, regardless the size, with suspicion of paradoxal embolism
- Patients with PVR > or egal 5 WU but <2/3 Systemic Vascular Resistance or Pulmonary Arterial Pressure < 2/3 systemic pressure and evidence of net Left-to Right shunt (Qp/Qs > 1,5)
- with the French Social Security System
Who cannot join
- Pregnant women and breastfeeding women
- Difficulties of cooperation (patient under assisted ventilation)
- Chronic Obstructive Pulmonary disease or respiratory failure
- Complex congenital heart disease
- Antiplatelet contraindication
- Patients under protection, vulnerable patients
Show all 10Show fewer
- No consent
- Contraindication of the non-invasive devices
- Physioflow (Manatec, France): patients with pacemaker, with a cardiorespiratory support and assistance, severe aortic insufficiency
- Innocor (Innovision, Odense, Denmark): to our knowledge, and according to the user instructions, there is no contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shunt Quantification in Atrial Septal Defect Using Inert Gas Rebreathing and Thoracic Bioimpedance: Comparison With the Gold Standard Method
Shunt quantification in atrial septal defect (ASD) is estimated by Echocardiography-Doppler, with the pulmonary-to-systemic blood flow ratio: Qp/Qs. Higher is the ratio, more important is the shunt, and the consequence on right ventricular function. A value higher than 1.5 is one of the criteria for percutaneous closure of Secundum ASD. Maatouk and al. have demonstrated that a shunt fraction (Qp/Qs) over 3 is a predictive factor of an incomplete reversibility of the right ventricular remodeling [1]. Even if the accuracy of Doppler echocardiography is admitted for Qp/Qs measurement, there is still some technical difficulties. Thus, the right cardiac catheterization for O2 consumption measurement by the direct Fick method is used. The major inconvenient is the potential risk of adverse effects. Non-invasive methods have been developed using physical properties (as the thoracic bioimpedance) or inert gas rebreathing technique. Thoracic Bioimpedance (TB) and inert gas rebreathing (IGR) techniques have been studies on healthy individual and different respiratory or cardiac diseases to evaluate the cardiac output (CO). TB and IGR measure the systemic and pulmonary blood flow respectively. Without shunt the pulmonary blood flow is equal to the systemic blood flow.
Thus, Investigator suppose that combine the two techniques in disease with shunt, will allow a quantification of the shunt fraction Qp/Qs as accurate as with the gold standard technique (Fick method and Echocardiography Doppler).
Read more
The purpose of the study is to evaluate the feasibility and the accuracy of the non-invasive measurement of the Qp/Qs ratio in secundum ASD using the IGR technique and the TB versus the two gold standard techniques: the Fick method and the Echocardiography-Doppler.
The study hypothesizes that the values of Qp et Qs determined by IGR et TB respectively are in the same range of values that the one determined by gold standard techniques.
Read the detailed description
Shunt quantification and their hemodynamic consequences have a major importance in the evaluation of heart diseases. Atrial septal defect (ASD) has an intracardiac left-to right shunt, leading to an over pulmonary output with ventricular and pulmonary effects. Measurements of the LTR in ASD requires the determination of the pulmonary blood flow (Qp) and the systemic blood flow (Qs).
Two gold standard techniques are usually used to measure the pulmonary to systemic blood flow ratio (Qp/Qs): either invasive by performing a right heart catheterization, with the direct Fick method, or non-invasive by using the Echocardiography-Doppler (ED) First determine by ED by the successively measure of the Qp at the pulmonary annular and the Qs at the aortic annular, this technique is largely available, reproducible and accurate.
However, some limits are pointed with this non-invasive gold standard method: underestimation of shunt quantification in case of large septal defect, the accuracy depends on the operator experience, the lack of precision to measure pulmonary annular area especially on adults leading to a wrong measure of the pulmonary blood flow.
In case of doubt about pulmonary hypertension or difficulties in hemodynamic evaluation, the cardiologists perform a right heart catheterization to measure the CO by the Fick method .
Concerning the other non-invasive approach, thoracic bioimpedance (TB) have been developed in the middle of the twenty-one centuries by Kubiceck to measure cardiovascular parameters in astronauts has been largely study. Moreover, hemodynamic parameters are not stable but varies continuously according to the "hemodynamic state".
High of interest in the field of the non-invasive hemodynamic device, Inert gas rebreathing (IGR) measures the pulmonary blood flow, at rest and on exercise in healthy patient and different cardiorespiratory diseases. The Innocor® (Innovision, Odense, Denmark) uses a rebreathing bag containing a mixing of N2O (0,5%) SF6 (0,1%) and O2 (28%) diluted with atmospheric air. At the steady state of the insoluble inert gas, sulphur hexafluoride SF6, the wash out rate of N2O during rebreathing is calculated, which is proportional to the Qp. Many studies on healthy people confirms its accuracy, safety, reproducibility to measure CO . Agostoni et al. assess the Innocor® on patients with stable heart failure at rest and exercise comparatively to Thermodilution (ThD) and Fick method . They found a good correlation between the three methods at exercise. They found a tendency on underestimation of the IGR technique for CO measurement in comparison to Fick method . Few studies are available on the IGR technique use in CHD population. Tested on a paediatric population, investigators have proved its feasibility on exercise.Secondary they focused on ASD paediatric population. The CO were measured at exercise before and after percutaneous or surgical closured. They confirm the reproducibility, and feasibility of the IGR . Investigators found a similar agreement with the Fick method for patients with CHD without shunting or with right-to-left shunt .
To our knowledge, no study has focused on the concomitant used of two non-invasive technique to measure the shunt fraction in diseases with shunt. Some have suggested the interest of such a method in chronic obstructive pulmonary disease (COPD) .In fact, CO measured at rest and exercise shows a statistical difference between the IGR and TB due to the shunt effect and right-to-left shunt in COPD. Thus, the IGR and TB determine a pulmonary cardiac output (Qp) and a systemic cardiac output (Qs) respectively.
Based on these results, Investigator hypothesis that the combined used of the IGR and TB will enhance the precision and accuracy of the shunt fraction measurement.
The aim of this study is to validate the double non-invasive pulmonary-to-systemic ratio measurements on ostium secundum ASD in comparison to the two-gold standard method: the direct Fick method and the Echocardiography-Doppler.
- Conditions
- Congenital Heart Diseases, Hemodynamic, Cardiac Output
- Being tested
- Innocor®, Physioflow®
- Keywords
- Pulmonary to systemic blood flow, Non-invasive measurement, Inert gas rebreathing, Bioimpedance cardiograph, Atrial Septal Defect, Congenital heart disease, Cardiac Output
- Medical subject headings
- Heart Defects, Congenital, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innocor®Device
Inert gas rebreathing device: Innocor® (Innovision, Odense, Denmark)
Physioflow®Device
Bioimpedance cardiograph: Physioflow® (Manatec, France)
| Study group | Role | What they receive |
|---|---|---|
| patients with Atrial septal defect type Ostium Secundum | Experimental | patients with Atrial septal defect type Ostium Secundum, eligible for an interventional closure Receives: Device: Innocor®; Device: Physioflow® |
What is being measured
The primary outcome is the main question the study is designed to answer.
shunt fraction
Accuracy of Qp/Qs ratio measurements by the double non-invasive technique and the gold standard method (non-invasive: Echocardiography Doppler; invasive: direct Fick method) before interventional closure of ASD
Measured: at 1 hour
Secondary outcomes (1)
shunt fraction Qp/Qs after closure
Qp/Qs measurements by the double non-invasive technique in comparison to Echocardiography-Doppler after interventional closure
Measured: at 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start18 Jul 2018
- Primary completion6 Apr 2022
- Study completion3 Oct 2022
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseasesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Sport Medicine Department, CHU Clermont-Ferrand, Cardiology and Vascular Department, CHU Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Ruddy RICHARD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437148
- Sponsor's protocol ID
- CHU-373
- Other IDs
- 2017-A03149-44
- Acronym
- NISQIC
- Status last verified
- Oct 2022
- First submitted
- 31 Jan 2018
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maatouk F, Ben Farhat M, Betbout F, Gamra H, Ben Hamda K, Jarrar M, Hammami S, Added F, Ben Gadha N, Dridi Z. [Right ventricular dilatation and intraventricular septal motion after surgical closure of atrial septal defect]. Arch Mal Coeur Vaiss. 2001 Mar;94(3):204-10. French.
PubMed 11338255Okamoto M, Miyatake K, Kinoshita N, Nakasone I, Ohwa M, Takao S, Fusejima K, Sakakibara H, Nimura Y. [Noninvasive determination of the ratio of pulmonary to systemic blood flow with two-dimensional Doppler echocardiography: efficacy and limitation]. J Cardiogr. 1984 Jun;14(1):189-200. Japanese.
PubMed 6520422Sanders SP, Yeager S, Williams RG. Measurement of systemic and pulmonary blood flow and QP/QS ratio using Doppler and two-dimensional echocardiography. Am J Cardiol. 1983 Mar 15;51(6):952-6. doi: 10.1016/s0002-9149(83)80172-6.
PubMed 6829471Baumgartner H, Bonhoeffer P, De Groot NM, de Haan F, Deanfield JE, Galie N, Gatzoulis MA, Gohlke-Baerwolf C, Kaemmerer H, Kilner P, Meijboom F, Mulder BJ, Oechslin E, Oliver JM, Serraf A, Szatmari A, Thaulow E, Vouhe PR, Walma E; Task Force on the Management of Grown-up Congenital Heart Disease of the European Society of Cardiology (ESC); Association for European Paediatric Cardiology (AEPC); ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010 Dec;31(23):2915-57. doi: 10.1093/eurheartj/ehq249. Epub 2010 Aug 27. No abstract available.
PubMed 20801927Kubicek WG, Karnegis JN, Patterson RP, Witsoe DA, Mattson RH. Development and evaluation of an impedance cardiac output system. Aerosp Med. 1966 Dec;37(12):1208-12. No abstract available.
PubMed 5339656Miles DS, Gotshall RW, Golden JC, Tuuri DT, Beekman RH 3rd, Dillon T. Accuracy of electrical impedance cardiography for measuring cardiac output in children with congenital heart defects. Am J Cardiol. 1988 Mar 1;61(8):612-6. doi: 10.1016/0002-9149(88)90775-8.
PubMed 3344687Taylor K, La Rotta G, McCrindle BW, Manlhiot C, Redington A, Holtby H. A comparison of cardiac output by thoracic impedance and direct fick in children with congenital heart disease undergoing diagnostic cardiac catheterization. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):776-9. doi: 10.1053/j.jvca.2011.05.002.
PubMed 21684761Fontana P, Boutellier U, Toigo M. Reliability of measurements with Innocor during exercise. Int J Sports Med. 2009 Oct;30(10):747-53. doi: 10.1055/s-0029-1225340. Epub 2009 Jul 29.
PubMed 19642059Dong L, Wang JA, Jiang CY. Validation of the use of foreign gas rebreathing method for non-invasive determination of cardiac output in heart disease patients. J Zhejiang Univ Sci B. 2005 Dec;6(12):1157-62. doi: 10.1631/jzus.2005.B1157.
PubMed 16358372Warburton DE, Haykowsky MJ, Quinney HA, Humen DP, Teo KK. Reliability and validity of measures of cardiac output during incremental to maximal aerobic exercise. Part II: Novel techniques and new advances. Sports Med. 1999 Apr;27(4):241-60. doi: 10.2165/00007256-199927040-00004.
PubMed 10367334Agostoni P, Cattadori G, Apostolo A, Contini M, Palermo P, Marenzi G, Wasserman K. Noninvasive measurement of cardiac output during exercise by inert gas rebreathing technique: a new tool for heart failure evaluation. J Am Coll Cardiol. 2005 Nov 1;46(9):1779-81. doi: 10.1016/j.jacc.2005.08.005. Epub 2005 Oct 10. No abstract available.
PubMed 16256885Gabrielsen A, Videbaek R, Schou M, Damgaard M, Kastrup J, Norsk P. Non-invasive measurement of cardiac output in heart failure patients using a new foreign gas rebreathing technique. Clin Sci (Lond). 2002 Feb;102(2):247-52.
PubMed 11834145Wiegand G, Kerst G, Baden W, Hofbeck M. Noninvasive cardiac output determination for children by the inert gas-rebreathing method. Pediatr Cardiol. 2010 Nov;31(8):1214-8. doi: 10.1007/s00246-010-9806-6. Epub 2010 Oct 13.
PubMed 20941596Wiegand G, Binder W, Ulmer H, Kaulitz R, Riethmueller J, Hofbeck M. Noninvasive cardiac output measurement at rest and during exercise in pediatric patients after interventional or surgical atrial septal defect closure. Pediatr Cardiol. 2012 Oct;33(7):1109-14. doi: 10.1007/s00246-012-0239-2. Epub 2012 Feb 22.
PubMed 22354224Marma AK, Opotowsky AR, Fromm BS, Ubeda-Tikkanen A, Porras D, Rhodes J. Noninvasive cardiac output estimation by inert gas rebreathing in pediatric and congenital heart disease. Am Heart J. 2016 Apr;174:80-8. doi: 10.1016/j.ahj.2016.01.006. Epub 2016 Jan 19.
PubMed 26995373
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shunt Quantification in Atrial Septal Defect Using Inert Gas Rebreathing and Thoracic Bioimpedance: Comparison With the Gold Standard Method
- ClinicalTrials.gov ID
- NCT03437148
- Acronym / sponsor ID
- NISQIC / CHU-373
- Conditions
- Congenital Heart Diseases, Hemodynamic, Cardiac Output
- Keywords
- Pulmonary to systemic blood flow, Non-invasive measurement, Inert gas rebreathing, Bioimpedance cardiograph, Atrial Septal Defect, Congenital heart disease, Cardiac Output
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Sport Medicine Department, CHU Clermont-Ferrand, Cardiology and Vascular Department, CHU Clermont-Ferrand
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 19 Feb 2018 (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.
Shunt quantification in atrial septal defect (ASD) is estimated by Echocardiography-Doppler, with the pulmonary-to-systemic blood flow ratio: Qp/Qs. Higher is the ratio, more important is the shunt, and the consequence on right ventricular function. A value higher than 1.5 is one of the criteria for percutaneous closure of Secundum ASD. Maatouk and al. have demonstrated that a shunt fraction (Qp/Qs) over 3 is a predictive factor of an incomplete reversibility of the right ventricular remodeling [1]. Even if the accuracy of Doppler echocardiography is admitted for Qp/Qs measurement, there is still some technical difficulties. Thus, the right cardiac catheterization for O2 consumption measurement by the direct Fick method is used. The major inconvenient is the potential risk of adverse effects. Non-invasive methods have been developed using physical properties (as the thoracic bioimpedance) or inert gas rebreathing technique. Thoracic Bioimpedance (TB) and inert gas rebreathing (IGR) techniques have been studies on healthy individual and different respiratory or cardiac diseases to evaluate the cardiac output (CO). TB and IGR measure the systemic and pulmonary blood flow respectively. Without shunt the pulmonary blood flow is equal to the systemic blood flow.
Thus, Investigator suppose that combine the two techniques in disease with shunt, will allow a quantification of the shunt fraction Qp/Qs as accurate as with the gold standard technique (Fick method and Echocardiography Doppler).
The purpose of the study is to evaluate the feasibility and the accuracy of the non-invasive measurement of the Qp/Qs ratio in secundum ASD using the IGR technique and the TB versus the two gold standard techniques: the Fick method and the Echocardiography-Doppler.
The study hypothesizes that the values of Qp et Qs determined by IGR et TB respectively are in the same range of values that the one determined by gold standard techniques.
Detailed description
Shunt quantification and their hemodynamic consequences have a major importance in the evaluation of heart diseases. Atrial septal defect (ASD) has an intracardiac left-to right shunt, leading to an over pulmonary output with ventricular and pulmonary effects. Measurements of the LTR in ASD requires the determination of the pulmonary blood flow (Qp) and the systemic blood flow (Qs).
Two gold standard techniques are usually used to measure the pulmonary to systemic blood flow ratio (Qp/Qs): either invasive by performing a right heart catheterization, with the direct Fick method, or non-invasive by using the Echocardiography-Doppler (ED) First determine by ED by the successively measure of the Qp at the pulmonary annular and the Qs at the aortic annular, this technique is largely available, reproducible and accurate.
However, some limits are pointed with this non-invasive gold standard method: underestimation of shunt quantification in case of large septal defect, the accuracy depends on the operator experience, the lack of precision to measure pulmonary annular area especially on adults leading to a wrong measure of the pulmonary blood flow.
In case of doubt about pulmonary hypertension or difficulties in hemodynamic evaluation, the cardiologists perform a right heart catheterization to measure the CO by the Fick method .
Concerning the other non-invasive approach, thoracic bioimpedance (TB) have been developed in the middle of the twenty-one centuries by Kubiceck to measure cardiovascular parameters in astronauts has been largely study. Moreover, hemodynamic parameters are not stable but varies continuously according to the "hemodynamic state".
High of interest in the field of the non-invasive hemodynamic device, Inert gas rebreathing (IGR) measures the pulmonary blood flow, at rest and on exercise in healthy patient and different cardiorespiratory diseases. The Innocor® (Innovision, Odense, Denmark) uses a rebreathing bag containing a mixing of N2O (0,5%) SF6 (0,1%) and O2 (28%) diluted with atmospheric air. At the steady state of the insoluble inert gas, sulphur hexafluoride SF6, the wash out rate of N2O during rebreathing is calculated, which is proportional to the Qp. Many studies on healthy people confirms its accuracy, safety, reproducibility to measure CO . Agostoni et al. assess the Innocor® on patients with stable heart failure at rest and exercise comparatively to Thermodilution (ThD) and Fick method . They found a good correlation between the three methods at exercise. They found a tendency on underestimation of the IGR technique for CO measurement in comparison to Fick method . Few studies are available on the IGR technique use in CHD population. Tested on a paediatric population, investigators have proved its feasibility on exercise.Secondary they focused on ASD paediatric population. The CO were measured at exercise before and after percutaneous or surgical closured. They confirm the reproducibility, and feasibility of the IGR . Investigators found a similar agreement with the Fick method for patients with CHD without shunting or with right-to-left shunt .
To our knowledge, no study has focused on the concomitant used of two non-invasive technique to measure the shunt fraction in diseases with shunt. Some have suggested the interest of such a method in chronic obstructive pulmonary disease (COPD) .In fact, CO measured at rest and exercise shows a statistical difference between the IGR and TB due to the shunt effect and right-to-left shunt in COPD. Thus, the IGR and TB determine a pulmonary cardiac output (Qp) and a systemic cardiac output (Qs) respectively.
Based on these results, Investigator hypothesis that the combined used of the IGR and TB will enhance the precision and accuracy of the shunt fraction measurement.
The aim of this study is to validate the double non-invasive pulmonary-to-systemic ratio measurements on ostium secundum ASD in comparison to the two-gold standard method: the direct Fick method and the Echocardiography-Doppler.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Atrial septal defect type Ostium Secundum | Experimental | Device: Innocor®, Device: Physioflow®patients with Atrial septal defect type Ostium Secundum, eligible for an interventional closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- cooperate patients over 18 years, having a OS ASD with an indication of interventional closure according to the European Cardiology society guidelines of 2010.
- Patients with significant shunt (signs of right ventricular volume overload) and Pulmonary Vascular Resistance (PVR) <5WU
- ASD, regardless the size, with suspicion of paradoxal embolism
- Patients with PVR > or egal 5 WU but <2/3 Systemic Vascular Resistance or Pulmonary Arterial Pressure < 2/3 systemic pressure and evidence of net Left-to Right shunt (Qp/Qs > 1,5)
- with the French Social Security System
Key exclusion criteria (10 listed)
- Pregnant women and breastfeeding women
- Difficulties of cooperation (patient under assisted ventilation)
- Chronic Obstructive Pulmonary disease or respiratory failure
- Complex congenital heart disease
- Antiplatelet contraindication
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 |
|---|---|---|
| Innocor®Inert gas rebreathing device: Innocor® (Innovision, Odense, Denmark) | Device | patients with Atrial septal defect type Ostium Secundum |
| Physioflow®Bioimpedance cardiograph: Physioflow® (Manatec, France) | Device | patients with Atrial septal defect type Ostium Secundum |
Primary outcome
shunt fraction
Time frame: at 1 hour
Accuracy of Qp/Qs ratio measurements by the double non-invasive technique and the gold standard method (non-invasive: Echocardiography Doppler; invasive: direct Fick method) before interventional closure of ASD
1 secondary outcome
shunt fraction Qp/Qs after closure
Time frame: at 1 hour
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 11338255Maatouk F, Ben Farhat M, Betbout F, Gamra H, Ben Hamda K, Jarrar M, Hammami S, Added F, Ben Gadha N, Dridi Z. [Right ventricular dilatation and intraventricular septal motion after surgical closure of atrial septal defect]. Arch Mal Coeur Vaiss. 2001 Mar;94(3):204-10. French.
- Background: PubMed 6520422Okamoto M, Miyatake K, Kinoshita N, Nakasone I, Ohwa M, Takao S, Fusejima K, Sakakibara H, Nimura Y. [Noninvasive determination of the ratio of pulmonary to systemic blood flow with two-dimensional Doppler echocardiography: efficacy and limitation]. J Cardiogr. 1984 Jun;14(1):189-200. Japanese.
- Background: PubMed 6829471Sanders SP, Yeager S, Williams RG. Measurement of systemic and pulmonary blood flow and QP/QS ratio using Doppler and two-dimensional echocardiography. Am J Cardiol. 1983 Mar 15;51(6):952-6. doi: 10.1016/s0002-9149(83)80172-6.
- Background: PubMed 20801927Baumgartner H, Bonhoeffer P, De Groot NM, de Haan F, Deanfield JE, Galie N, Gatzoulis MA, Gohlke-Baerwolf C, Kaemmerer H, Kilner P, Meijboom F, Mulder BJ, Oechslin E, Oliver JM, Serraf A, Szatmari A, Thaulow E, Vouhe PR, Walma E; Task Force on the Management of Grown-up Congenital Heart Disease of the European Society of Cardiology (ESC); Association for European Paediatric Cardiology (AEPC); ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010 Dec;31(23):2915-57. doi: 10.1093/eurheartj/ehq249. Epub 2010 Aug 27. No abstract available.
- Background: PubMed 5339656Kubicek WG, Karnegis JN, Patterson RP, Witsoe DA, Mattson RH. Development and evaluation of an impedance cardiac output system. Aerosp Med. 1966 Dec;37(12):1208-12. No abstract available.
- Background: PubMed 3344687Miles DS, Gotshall RW, Golden JC, Tuuri DT, Beekman RH 3rd, Dillon T. Accuracy of electrical impedance cardiography for measuring cardiac output in children with congenital heart defects. Am J Cardiol. 1988 Mar 1;61(8):612-6. doi: 10.1016/0002-9149(88)90775-8.
- Background: PubMed 21684761Taylor K, La Rotta G, McCrindle BW, Manlhiot C, Redington A, Holtby H. A comparison of cardiac output by thoracic impedance and direct fick in children with congenital heart disease undergoing diagnostic cardiac catheterization. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):776-9. doi: 10.1053/j.jvca.2011.05.002.
- Background: PubMed 19642059Fontana P, Boutellier U, Toigo M. Reliability of measurements with Innocor during exercise. Int J Sports Med. 2009 Oct;30(10):747-53. doi: 10.1055/s-0029-1225340. Epub 2009 Jul 29.
- Background: PubMed 16358372Dong L, Wang JA, Jiang CY. Validation of the use of foreign gas rebreathing method for non-invasive determination of cardiac output in heart disease patients. J Zhejiang Univ Sci B. 2005 Dec;6(12):1157-62. doi: 10.1631/jzus.2005.B1157.
- Background: PubMed 10367334Warburton DE, Haykowsky MJ, Quinney HA, Humen DP, Teo KK. Reliability and validity of measures of cardiac output during incremental to maximal aerobic exercise. Part II: Novel techniques and new advances. Sports Med. 1999 Apr;27(4):241-60. doi: 10.2165/00007256-199927040-00004.
- Background: PubMed 16256885Agostoni P, Cattadori G, Apostolo A, Contini M, Palermo P, Marenzi G, Wasserman K. Noninvasive measurement of cardiac output during exercise by inert gas rebreathing technique: a new tool for heart failure evaluation. J Am Coll Cardiol. 2005 Nov 1;46(9):1779-81. doi: 10.1016/j.jacc.2005.08.005. Epub 2005 Oct 10. No abstract available.
- Background: PubMed 11834145Gabrielsen A, Videbaek R, Schou M, Damgaard M, Kastrup J, Norsk P. Non-invasive measurement of cardiac output in heart failure patients using a new foreign gas rebreathing technique. Clin Sci (Lond). 2002 Feb;102(2):247-52.
Related trials for Congenital Heart Diseases
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Ruddy RICHARD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innocor® and Physioflow® in people with Congenital Heart Diseases and Hemodynamic, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Oct 2022. 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 France. 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 was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
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?
shunt fraction (time frame: at 1 hour). 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 NCT03437148, which also lists 17 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 10 Oct 2022.