Non-Invasive Shunt Quantification in Interatrial Communication

NCT03437148 | Terminated

• 2 other identifiers: CHU-3732017-A03149-44
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  at 1 hour

Secondary Outcomes (1)

• shunt fraction Qp/Qs after closure

  at 1 hour

Study Arms (1)

patients with Atrial septal defect type Ostium Secundum

EXPERIMENTAL

patients with Atrial septal defect type Ostium Secundum, eligible for an interventional closure

Device: Innocor®; Device: Physioflow®

Interventions

Innocor® DEVICE

Inert gas rebreathing device: Innocor® (Innovision, Odense, Denmark)

patients with Atrial septal defect type Ostium Secundum

Physioflow® DEVICE

Bioimpedance cardiograph: Physioflow® (Manatec, France)

patients with Atrial septal defect type Ostium Secundum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sport Medicine Department, CHU Clermont-Ferrand: collaborator
• University Hospital, Clermont-Ferrand: lead
• Cardiology and Vascular Department, CHU Clermont-Ferrand: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (17)

• 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.

  PMID: 11338255 BACKGROUND

• Okamoto 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.

  PMID: 6520422 BACKGROUND

• Sanders 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.

  PMID: 6829471 BACKGROUND

• Baumgartner 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.

  PMID: 20801927 BACKGROUND

• Kubicek 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.

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• Miles 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.

  PMID: 3344687 BACKGROUND

• Taylor 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.

  PMID: 21684761 BACKGROUND

• Fontana 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.

  PMID: 19642059 BACKGROUND

• Dong 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.

  PMID: 16358372 BACKGROUND

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  PMID: 16256885 BACKGROUND

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  PMID: 11834145 BACKGROUND

• Wiegand 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.

  PMID: 20941596 BACKGROUND

• Wiegand 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.

  PMID: 22354224 BACKGROUND

• Marma 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.

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• Perrault H, Richard R, Kapchinsky S, Baril J, Bourbeau J, Taivassalo T. Addressing Assumptions for the Use of Non-invasive Cardiac Output Measurement Techniques During Exercise in COPD. COPD. 2016;13(1):75-81. doi: 10.3109/15412555.2015.1043985. Epub 2015 Sep 25.

  PMID: 26408087 BACKGROUND

• Filaire L, Chalard A, Perrault H, Tresorier R, Lusson JR, Pereira B, Costes F, Dauphin C, Richard R. Validation of intracardiac shunt using thoracic bioimpedance and inert gas rebreathing in adults before and after percutaneous closure of atrial septal defect in a cardiology research unit: study protocol. BMJ Open. 2019 May 27;9(5):e024389. doi: 10.1136/bmjopen-2018-024389.

  PMID: 31133575 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects

Study Officials

• Ruddy RICHARD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: NO MASKING
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 19, 2018
• Study Start: July 18, 2018
• Primary Completion: April 6, 2022
• Study Completion: October 3, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

FR (1)