Patent Ductus ArteriosesNCT07568002
Impact of Transcatheter Patent Ductus Arteriosus Closure on Left Atrial and Ventricular Remodeling in Adults and Adolescents.
An observational study of Patent Ductus Arterioses, run by Emil Magdy Badry.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Ductus Arterioses
- What is being tested?
- Transcatheter Patent Ductus Arteriosus Closure
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2026to 4 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with patent ductus arteriosus
Who may be able to join
- 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).
Who cannot join
- - 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read more
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).
Read the detailed description
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)
- Conditions
- Patent Ductus Arterioses
- Being tested
- Transcatheter Patent Ductus Arteriosus Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Patent Ductus Arteriosus ClosureProcedure or surgery
Transcatheter Patent Ductus Arteriosus Closure
| Study group | Role | What they receive |
|---|---|---|
| left atrial and ventricular Remodeling in Adults | Not described Receives: Procedure: Transcatheter Patent Ductus Arteriosus Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial strain parameters in lt atrium and ventricle before and after PDA ligation
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start3 Jun 2026 (estimated)
- Primary completion3 Jun 2028 (estimated)
- Study completion4 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emil Magdy Badry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emil Magdy Badry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568002
- Sponsor's protocol ID
- Adult transcatheter PDA close
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcatheter Patent Ductus Arteriosus Closure on Left Atrial and Ventricular Remodeling in Adults and Adolescents.
- ClinicalTrials.gov ID
- NCT07568002
- Acronym / sponsor ID
- Adult transcatheter PDA close
- Conditions
- Patent Ductus Arterioses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Emil Magdy BadryUniversity, hospital or other
- Study start
- 3 Jun 2026 (estimated)
- Primary completion
- 3 Jun 2028 (estimated)
- Study completion
- 4 Jul 2028 (estimated)
- First posted
- 5 May 2026 (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.
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).
Detailed description
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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| left atrial and ventricular Remodeling in Adults | – | Procedure: Transcatheter Patent Ductus Arteriosus Closure |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with patent ductus arteriosus
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- - 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.
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 |
|---|---|---|
| Transcatheter Patent Ductus Arteriosus ClosureTranscatheter Patent Ductus Arteriosus Closure | Procedure or surgery | left atrial and ventricular Remodeling in Adults |
Primary outcome
Change in myocardial strain parameters in lt atrium and ventricle before and after PDA ligation
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication1. 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
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arterioses, run by Emil Magdy Badry.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emil Magdy Badry, Resident doctor (+20 12 75470803, emilmagdy27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in myocardial strain parameters in lt atrium and ventricle before and after PDA ligation (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT07568002, which also lists 1 linked publication.
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 5 May 2026.