Status:
TERMINATED
Non-Invasive Shunt Quantification in Interatrial Communication
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Sport Medicine Department, CHU Clermont-Ferrand
Cardiology and Vascular Department, CHU Clermont-Ferrand
Conditions:
Congenital Heart Diseases
Hemodynamic
Eligibility:
All Genders
18+ years
Phase:
NA
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, a...
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03437148
Start Date
July 18 2018
End Date
October 3 2022
Last Update
October 10 2022
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003