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Clinical trials for Atrioventricular septal defect

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    4 result(s) found for: Atrioventricular septal defect. Displaying page 1 of 1.
    EudraCT Number: 2011-005440-98 Sponsor Protocol Number: Start Date*: 2012-04-12
    Sponsor Name:AKH Linz
    Full Title: Double blinded randomised trial for the evaluation of the effectiveness of prophylactic use of sildenafil for the prevention of pulmonary hypertensive crisis after congenital heart surgery
    Medical condition: Ventriculs septal defect, atrioventricular canal with pulmonary hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10010401 Congenital cardiovascular anomaly therapeutic procedures HLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003335-33 Sponsor Protocol Number: AC-055-305 Start Date*: 2013-02-27
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome.
    Medical condition: Eisenmenger Syndrome
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10058554 Eisenmenger's syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) BG (Completed) BE (Completed) DE (Completed) PT (Completed) NL (Completed) AT (Completed) ES (Completed) HU (Completed) CZ (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002533-11 Sponsor Protocol Number: AC-055-315 Start Date*: 2020-06-17
    Sponsor Name:ACTELION Pharmacteuticals Ltd.
    Full Title: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Toler...
    Medical condition: Pulmonary arterial hypertension
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10064911 Pulmonary arterial hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) CZ (Trial now transitioned) HU (Trial now transitioned) SE (Trial now transitioned) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) NO (Completed) SK (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
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    Query did not match any studies.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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