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Impact of Transcatheter Patent Ductus Arteriosus Closure on Left Atrial and Ventricular Remodeling in Adults and Adolescents.

28 april 2026 bijgewerkt door: Emil Magdy Badry

During the fetal life, small portion of the RV output passes to the lung through the pulmonary artery, while the greater portion is shunted to the descending aorta through the fetal ductus arteriosus (1) which is a connection between the left pulmonary artery and descending thoracic aorta just distal to the left subclavian artery.

With transition from intrauterine to extrauterine life, physiological changes occur resulting in left to right reversal of the shunt through the ductus arteriosus. Increased oxygenation after birth results in calcium and potassium channel activity ending in ductus closure(2).

Patent ductus arteriosus (PDA ) is a congenital heart disease(CHD) represents 6-11% of all CHDs (3) and results from failure of closure of the ductus beyond the third month of age(4).

However, there are a subset of patients who survive to adulthood undiagnosed, and it is present in adulthood with various clinical presentations. The clinical presentation, hemodynamics, and management of PDA presentation in adults depend on various factors, primarily the size of PDA, magnitude of shunting, and status of pulmonary vasculature (5).

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

During the fetal life, small portion of the RV output passes to the lung through the pulmonary artery, while the greater portion is shunted to the descending aorta through the fetal ductus arteriosus (1) which is a connection between the left pulmonary artery and descending thoracic aorta just distal to the left subclavian artery.

With transition from intrauterine to extrauterine life, physiological changes occur resulting in left to right reversal of the shunt through the ductus arteriosus. Increased oxygenation after birth results in calcium and potassium channel activity ending in ductus closure(2).

Patent ductus arteriosus (PDA ) is a congenital heart disease(CHD) represents 6-11% of all CHDs (3) and results from failure of closure of the ductus beyond the third month of age(4).

However, there are a subset of patients who survive to adulthood undiagnosed, and it is present in adulthood with various clinical presentations. The clinical presentation, hemodynamics, and management of PDA presentation in adults depend on various factors, primarily the size of PDA, magnitude of shunting, and status of pulmonary vasculature (5).

According to the diameter, and length of the duct, the systemic and pulmonary vascular resistance, the duct may be hemodynamically insignificant or may result in pulmonary over circulation with subsequent left sided heart volume overload(5).

This volume overload induces left heart remodeling manifested by left atrial and ventricular dilatation and hypertrophy to compensate for the increased wall stress. Some patients can compensate well and remain asymptomatic, while others can't and develop heart failure and LV systolic dysfunction (6).

Traditional two dimensional (2D) and doppler echocardiography is the cornerstone tool for the diagnosis of PDA, evaluation of the magnitude and direction of its shunting, and measuring the pulmonary artery pressure(6). Speckle tracking echocardiography (STE) is a relatively novel application that helps in the assessment of the LV and RV function by tracking the speckles seen on the grey scale images of the traditional echocardiography (7). Recent studies showed good correlation between the global longitudinal strain (GLS) measured by the STE , left and Right ventricular ejection fraction (LVEF , RVEF ) measured by traditional 2D echocardiography (8). In addition, other studies revealed that STE could detect subtle myocardial dysfunction in heart failure patients with preserved LVEF (9).

Since the first surgical PDA closure by Gross and Hubbard in 1939 and the later transcatheter PDA closure by Portsmann et al. in 1967, there have been many significant developments in the devices used to close a PDA(10)(11) . In the past 20 years, transcatheter closure has become the leading approach to closure of most PDAs(12).

Complete closure rates at follow-up generally exceed 90- 95% in most studies. Serious complications of transcatheter closure of the PDA are rare.

In real world, cardiologists intervene adult patients with PDAs and have access to variable PDA closure coils and devices that can be implanted through different techniques and theoretically this should induce reverse LV remodeling with improvement of the Left heart dimensions and function (13). Fewer studies assessed the adults with PDA and their findings were late improvement of the LVEF after PDA closure (15,16,23)

Studietype

Observationeel

Inschrijving (Geschat)

40

Contacten en locaties

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Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Patients with patent ductus arteriosus

Beschrijving

Inclusion Criteria:

  • All adults and adolescent patients > 0r equal 12 yrs old who are candidate for trans-catheter PDA closure according to the latest European society of cardiology (ESC) and American Heart Associations (AHA) guidelines for management of patients with congenital heart diseases (CHD)(24).

Exclusion Criteria:

  • - 1. Patients with small sized PDA which is silent by auscultation. 2. Patients with large sized PDA which is unsuitable for Trans-catheter closure.

    3. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).

    4. Patients with active infection or active infective endocarditis. 5. Patients refuse to participate in the study. 6. Patients with diabetes, systemic hypertension and ischemic heart diseases. 7. Patients with associated congenital or acquired cardiac lesions that may affect/interfere with the LV mechanics.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
left atrial and ventricular Remodeling in Adults
Transcatheter Patent Ductus Arteriosus Closure

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in myocardial strain parameters in lt atrium and ventricle before and after PDA ligation
Tijdsspanne: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • 1. Morton S, Brodsky D. Fetal Physiology and the Transition to Extrauterine Life. 2. Weir EK, Obreztchikova M, Vargese A, Cabrera JA, Peterson DA, Hong Z. Mechanisms of oxygen sensing: A key to therapy of pulmonary hypertension and patent ductus arteriosus. Vol. 155, British Journal of Pharmacology. 2008. p. 300-7. 3. P S, Jose J, George OK. Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults. Indian Heart J. 2018 Mar 1;70(2):308-15. 4. Forsey JT, Elmasry OA, Martin RP. Patent arterial duct. Orphanet J Rare Dis. 2009;4(1):1-9. 5. Schneider DJ, Moore JW. Patent Ductus Arteriosus. 2006 [cited 2021 Apr 4]; Available from: http://www.circulationaha.org 6. Schneider DJ. The Patent Ductus Arteriosus in Term Infants, Children, and A dults. Semin Perinatol [Internet]. 2012;36(2):146-53. Available from: http://dx.doi.org/10.1053/j.semperi.2011.09.025 7. Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux GG, et al. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese society of echocardiography. Eur J Echocardiogr [Internet]. 2011 Mar [cited 2017 Mar 25];12(3):167-205. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0894731711000484 8. Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zacà V, et al. Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med [Internet]. 2011 Jan [cited 2018 Jul 14];30(1):71-83. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21193707 9. Edvardsen T, Helle-Valle T, Smiseth OA. Systolic Dysfunction in Heart Failure with Normal Ejection Fraction: Speckle-Tracking Echocardiography. Prog Cardiovasc Dis. 2006 Nov;49(3):207-14. 10. Gross RE, Hubbard JP. Surgical ligation of a patent ductus arteriosus: Report of first successful case. J Am Med Assoc. 1939 Feb 25;112(8):729-3

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

3 juni 2026

Primaire voltooiing (Geschat)

3 juni 2028

Studie voltooiing (Geschat)

4 juli 2028

Studieregistratiedata

Eerst ingediend

21 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

28 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Adult transcatheter PDA close

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