ASD2(Secundum Atrial Septal Defect)NCT03867708
Outcomes of Transcatheter ASD Closure Guided by 3D-TEE
An observational study of ASD2(Secundum Atrial Septal Defect), run by Assiut University.
Trial summary
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance during percutaneous transcatheter closure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ASD2(Secundum Atrial Septal Defect)
- What is being tested?
- ASD device closure
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with secundum atrial septal defect with suitable rims for transcatheter device closure
Who may be able to join
- Patients with suitable indication for ASD closure according to recent guidelines :
- Impaired functional capacity.
- Right atrial and/or RV enlargement.
- Left-to-right shunt with [Qp: Qs] ≥1.5:1.
- Paradoxical embolism.
- Patients with isolated secundum ASD with sufficient rims suitable for device closure.
Who cannot join
- Small ASD with Qp/Qs <1.5:1 or no signs of RV volume overload
- A single defect too large for closure (>38 mm)
- Multiple ASDs unsuitable for percutaneous closure.
- Anterior, posterior, superior, or inferior rim <5 mm.
- Abnormal pulmonary venous drainage.
- Associated structural heart disease requiring cardiac surgery.
- ASD with severe pulmonary arterial hypertension and bidirectional or right-to-left shunting.
- Intracardiac thrombi diagnosed by echocardiography.
About this study
Official title: Outcomes of Transcatheter Closure of Secundum Atrial Septal Defect Guided by Three-dimensional Transesophageal Echocardiography
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance during percutaneous transcatheter closure. Proper device size selection is important for success of ASD device closure. 3D-TEE can assess the ASD morphology, maximal diameter, area and determine the device size without balloon sizing during percutaneous closure.There are some adverse outcomes reported in previous studies following transcatheter secundum ASD closure as: residual shunt, new onset atrial fibrillation(AF) and mitral regurgitation(MR)deterioration . These adverse outcomes are responsible for morbidity and mortality following transcatheter ASD closure, so it is essential to study risk factors associated with these adverse outcomes in order to minimize their incidence.The investigators will study the role of 3D-TEE in proper device size selection, also the percentage and predictors of adverse outcomes after device closure guided by 3D-TEE.
Read the detailed description
The investigators will include 80 patients in a prospective cohort study .
For all patients the following study tools will be done:
- Written consent.
- Detailed history including Age, sex, symptoms (NYHA class).
- Clinical examination.
- Electrocardiogram (ECG) (to detect baseline rhythm).
- Two-dimensional transthoracic echocardiography (2D TTE): All patients will undergo 2D TTE before device closure to assess:
- ASD (type, size, shunt direction).
- Pulsed Doppler quantification of the pulmonary (Qp) to systemic (Qs) blood flow ratio
- Right ventricle (RV) enlargement: RV linear dimensions are best measured from a RV-focused apical four-chamber view.
- RV systolic function by :
- Tricuspid annular plane systolic excursion(TAPSE) ,
- 2D RV fractional area change (FAC)= 100 X [(end-diastolic area - end-systolic area)/end-diastolic area)].
- Pulmonary artery systolic pressure (PASP).
- Grade of MR by Color Doppler: The color Doppler jet area of MR and left atrial area at the time of midsystole will be measured by the area trace method in the apical 4-chamber view, and the ratio of MR jet area to left atrial area will be calculated. The grade of MR will be determined by the ratio, where 0% to 10%>> none/trivial, 10% to 20% >> mild, 20% to 40% >>moderate, and >40% >> severe.
- Left ventricle (LV) systolic function by m-mode,
- LV diastolic function :
- Pulsed wave (PW) Doppler of trans-mitral flow during diastole.
- Tissue Doppler imaging (TDI).
- Three-dimensional transesophageal echocardiography (3D-TEE): All patients will undergo 3D-TEE before device closure of secundum ASD to assess:
- The number of defects.
- Defect size: The maximum dimension (length), minor dimension (width), and area by planimetry will be measured from the 3D en face view.
- ASD morphology will be categorized by the shape seen in the en face view. ASD will be defined as circular when the minor dimension is >75% of the maximum length. If the minor dimension is <75% of the maximum length ASD will be defined as having an oval shape. Asymmetric, irregularly shaped defects that are not elliptical will be defined as having a complex shape.
- The surrounding rims: aortic rim, atrioventricular (AV) rim, superior vena cava (SVC) rim, inferior vena cava (IVC) rim and posterior rim. According to recent study, the optimal ASD device size will be calculated as : Device size = 0.964 x 3Dmax - 2.622 x circular index +7.084 Where maximal ASD diameter on 3D-TEE (3Dmax) and the circular index is defined as the ratio of the maximal to minimal diameters on the 3D-TEE image.
- Transcatheter secundum ASD device closure procedure: All patients suitable for device closure will undergo transcatheter device closure procedure in cath lab under general anesthesia. After venous access is gained following local anesthesia via the right femoral vein, the ASD is crossed using a Multipurpose catheter. The Multipurpose catheter is then exchanged for a device-specific delivery system. Its tip is placed into the left atrium. The left-sided disk is then deployed and gently pulled back against the atrial septum under fluoroscopic guidance in a left anterior oblique projection. To deploy the right atrial disc, tension is maintained on the delivery cable while the delivery sheath is further withdrawn. The whole procedure will be under fluoroscopic and 3D-TEE guidance. Device size that will be used in ASD closure according to the previously mentioned formula based on 3D-TEE measurements.
- Follow up:
- Clinical follow up for 24 hours to detect post-ASD closure acute heart failure.
- 2D-TTE will be performed 24 hours post-procedure to visualize the device position and to look for residual shunting and MR grade using color Doppler.
- Clinical follow up, ECG and 2D-TTE at 6-month follow up to detect new onset AF, residual shunt and MR deterioration.
- After 6 months of device closure :
Patients will be divided into two groups according to occurrence of adverse outcomes (residual shunt , MR deterioration and new onset AF ) and the following predictors will be evaluated in each group and their influence on occurrence of these adverse outcomes:
Echocardiographic data:
- RV systolic function by TAPSE and FAC on 2D-TTE.
- LV systolic function by m-mode on 2D-TTE.
- LV diastolic function on 2D-TTE.
- Estimated PASP on 2D-TTE.
- ASD shape on 3D-TEE.
- ASD maximal diameter on 3D-TEE.
- ASD minimal diameter on 3D-TEE.
- ASD area on 3D-TEE.
- Size of implanted device.
- Conditions
- ASD2(Secundum Atrial Septal Defect)
- Being tested
- ASD device closure
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD device closureRadiation
transcatheter secundum ASD device closure
| Study group | Role | What they receive |
|---|---|---|
| patients with residual shunt | patient with residual left to right shunt detected by 2D-TTE at 6 month follow up after ASD device closure guided by 3D-TEE Receives: Radiation: ASD device closure | |
| patients without residual shunt | patient without residual left to right shunt by 2D-TTE at 6 month follow up after ASD device closure guided by 3D-TEE Receives: Radiation: ASD device closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of residual shunt, MR deterioration and new onset AF following 3D-TEE guided ASD closure
Detection of residual shunt and MR deterioration by 2D-TTE and new-onset AF by ECG at six month follow up after ASD device closure
Measured: six months
Secondary outcomes (1)
Clinical outcomes after six months
Detection of mortality , cerebrovascular stroke and heart failure after six months of ASD device closure
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: No participants found
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ASD2(Secundum Atrial Septal Defect)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Aboelkasem Ali Mousa, Assiut University
- Investigators
- Mohamed Mousa, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867708
- Sponsor's protocol ID
- ASD closure guided by 3D-TEE
- Status last verified
- Sep 2020
- First submitted
- 6 Mar 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alnasser S, Lee D, Austin PC, Labos C, Osten M, Lightfoot DT, Kutty S, Shah A, Meier L, Benson L, Horlick E. Long term outcomes among adults post transcatheter atrial septal defect closure: Systematic review and meta-analysis. Int J Cardiol. 2018 Nov 1;270:126-132. doi: 10.1016/j.ijcard.2018.06.076. Epub 2018 Jul 12.
PubMed 30054146Villablanca PA, Briston DA, Rodes-Cabau J, Briceno DF, Rao G, Aljoudi M, Shah AM, Mohananey D, Gupta T, Makkiya M, Ramakrishna H, Garcia MJ, Pass RH, Peek G, Zaidi AN. Treatment options for the closure of secundum atrial septal defects: A systematic review and meta-analysis. Int J Cardiol. 2017 Aug 15;241:149-155. doi: 10.1016/j.ijcard.2017.03.073. Epub 2017 Mar 24.
PubMed 28390741Silvestry FE, Cohen MS, Armsby LB, Burkule NJ, Fleishman CE, Hijazi ZM, Lang RM, Rome JJ, Wang Y; American Society of Echocardiography; Society for Cardiac Angiography and Interventions. Guidelines for the Echocardiographic Assessment of Atrial Septal Defect and Patent Foramen Ovale: From the American Society of Echocardiography and Society for Cardiac Angiography and Interventions. J Am Soc Echocardiogr. 2015 Aug;28(8):910-58. doi: 10.1016/j.echo.2015.05.015. No abstract available.
PubMed 26239900Chessa M, Carminati M, Butera G, Bini RM, Drago M, Rosti L, Giamberti A, Pome G, Bossone E, Frigiola A. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol. 2002 Mar 20;39(6):1061-5. doi: 10.1016/s0735-1097(02)01711-4.
PubMed 11897451Rao PS, Langhough R. Relationship of echocardiographic, shunt flow, and angiographic size to the stretched diameter of the atrial septal defect. Am Heart J. 1991 Aug;122(2):505-8. doi: 10.1016/0002-8703(91)91008-b.
PubMed 1858633Gupta SK, Sivasankaran S, Bijulal S, Tharakan JM, Harikrishnan S, Ajit K. Trans-catheter closure of atrial septal defect: Balloon sizing or no Balloon sizing - single centre experience. Ann Pediatr Cardiol. 2011 Jan;4(1):28-33. doi: 10.4103/0974-2069.79619.
PubMed 21677801Kong WK. The relation between atrial septal defect area, diameter and shape using balloon sizing and three-dimensional transoesophageal echocardiography during percutaneous closure using occlutech device. Journal of the American College of Cardiology. 2017;69(11 Supplement):1493.
Scacciatella P, Marra S, Pullara A, Conrotto F, Marchetti M, Ferraro G, Pavani M, Biasco L, Bongiovanni D, Gaita F, Orzan F. Percutaneous closure of atrial septal defect in adults: very long-term clinical outcome and effects on aortic and mitral valve function. J Invasive Cardiol. 2015 Jan;27(1):65-9.
PubMed 25589703Akagi T, Fujii Y, Takaya Y, Takahashi S, et al. Clinical benefit of transcatheter closure for newly developed atrial fibrillation in adult patients with atrial septal defect. Journal of the American College of Cardiology. 2018;71(11):A549.
Takaya Y, Kijima Y, Akagi T, Nakagawa K, Oe H, Taniguchi M, Sano S, Ito H. Fate of Mitral Regurgitation After Transcatheter Closure of Atrial Septal Defect in Adults. Am J Cardiol. 2015 Aug 1;116(3):458-62. doi: 10.1016/j.amjcard.2015.04.042. Epub 2015 May 7.
PubMed 26026868Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Apr 2;73(12):e81-e192. doi: 10.1016/j.jacc.2018.08.1029. Epub 2018 Aug 16. No abstract available.
PubMed 30121239Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
PubMed 25559473Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859Johri AM, Witzke C, Solis J, Palacios IF, Inglessis I, Picard MH, Passeri JJ. Real-time three-dimensional transesophageal echocardiography in patients with secundum atrial septal defects: outcomes following transcatheter closure. J Am Soc Echocardiogr. 2011 Apr;24(4):431-7. doi: 10.1016/j.echo.2010.12.011. Epub 2011 Jan 22.
PubMed 21262563Jang JY, Heo R, Cho MS, Bae J, Hong JA, Lee S, Ahn JM, Park DW, Kim DH, Kang DH, Song JK, Song JM. Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial septal defect without balloon sizing. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):684-689. doi: 10.1093/ehjci/jex153.
PubMed 28633478
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Transcatheter Closure of Secundum Atrial Septal Defect Guided by Three-dimensional Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT03867708
- Acronym / sponsor ID
- ASD closure guided by 3D-TEE
- Conditions
- ASD2(Secundum Atrial Septal Defect)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants found
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 8 Mar 2019 (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.
Atrial Septal Defect (ASD) is a common cardiac diagnosis among adults.Three-dimensional transesophageal echocardiography (3D-TEE) improve the visualization of ASD, its rims and surrounding structures and can be used for guidance during percutaneous transcatheter closure. Proper device size selection is important for success of ASD device closure. 3D-TEE can assess the ASD morphology, maximal diameter, area and determine the device size without balloon sizing during percutaneous closure.There are some adverse outcomes reported in previous studies following transcatheter secundum ASD closure as: residual shunt, new onset atrial fibrillation(AF) and mitral regurgitation(MR)deterioration . These adverse outcomes are responsible for morbidity and mortality following transcatheter ASD closure, so it is essential to study risk factors associated with these adverse outcomes in order to minimize their incidence.The investigators will study the role of 3D-TEE in proper device size selection, also the percentage and predictors of adverse outcomes after device closure guided by 3D-TEE.
Detailed description
The investigators will include 80 patients in a prospective cohort study .
For all patients the following study tools will be done:
- Written consent.
- Detailed history including Age, sex, symptoms (NYHA class).
- Clinical examination.
- Electrocardiogram (ECG) (to detect baseline rhythm).
- Two-dimensional transthoracic echocardiography (2D TTE): All patients will undergo 2D TTE before device closure to assess:
- ASD (type, size, shunt direction).
- Pulsed Doppler quantification of the pulmonary (Qp) to systemic (Qs) blood flow ratio
- Right ventricle (RV) enlargement: RV linear dimensions are best measured from a RV-focused apical four-chamber view.
- RV systolic function by :
- Tricuspid annular plane systolic excursion(TAPSE) ,
- 2D RV fractional area change (FAC)= 100 X [(end-diastolic area - end-systolic area)/end-diastolic area)].
- Pulmonary artery systolic pressure (PASP).
- Grade of MR by Color Doppler: The color Doppler jet area of MR and left atrial area at the time of midsystole will be measured by the area trace method in the apical 4-chamber view, and the ratio of MR jet area to left atrial area will be calculated. The grade of MR will be determined by the ratio, where 0% to 10%>> none/trivial, 10% to 20% >> mild, 20% to 40% >>moderate, and >40% >> severe.
- Left ventricle (LV) systolic function by m-mode,
- LV diastolic function :
- Pulsed wave (PW) Doppler of trans-mitral flow during diastole.
- Tissue Doppler imaging (TDI).
- Three-dimensional transesophageal echocardiography (3D-TEE): All patients will undergo 3D-TEE before device closure of secundum ASD to assess:
- The number of defects.
- Defect size: The maximum dimension (length), minor dimension (width), and area by planimetry will be measured from the 3D en face view.
- ASD morphology will be categorized by the shape seen in the en face view. ASD will be defined as circular when the minor dimension is >75% of the maximum length. If the minor dimension is <75% of the maximum length ASD will be defined as having an oval shape. Asymmetric, irregularly shaped defects that are not elliptical will be defined as having a complex shape.
- The surrounding rims: aortic rim, atrioventricular (AV) rim, superior vena cava (SVC) rim, inferior vena cava (IVC) rim and posterior rim. According to recent study, the optimal ASD device size will be calculated as : Device size = 0.964 x 3Dmax - 2.622 x circular index +7.084 Where maximal ASD diameter on 3D-TEE (3Dmax) and the circular index is defined as the ratio of the maximal to minimal diameters on the 3D-TEE image.
- Transcatheter secundum ASD device closure procedure: All patients suitable for device closure will undergo transcatheter device closure procedure in cath lab under general anesthesia. After venous access is gained following local anesthesia via the right femoral vein, the ASD is crossed using a Multipurpose catheter. The Multipurpose catheter is then exchanged for a device-specific delivery system. Its tip is placed into the left atrium. The left-sided disk is then deployed and gently pulled back against the atrial septum under fluoroscopic guidance in a left anterior oblique projection. To deploy the right atrial disc, tension is maintained on the delivery cable while the delivery sheath is further withdrawn. The whole procedure will be under fluoroscopic and 3D-TEE guidance. Device size that will be used in ASD closure according to the previously mentioned formula based on 3D-TEE measurements.
- Follow up:
- Clinical follow up for 24 hours to detect post-ASD closure acute heart failure.
- 2D-TTE will be performed 24 hours post-procedure to visualize the device position and to look for residual shunting and MR grade using color Doppler.
- Clinical follow up, ECG and 2D-TTE at 6-month follow up to detect new onset AF, residual shunt and MR deterioration.
- After 6 months of device closure :
Patients will be divided into two groups according to occurrence of adverse outcomes (residual shunt , MR deterioration and new onset AF ) and the following predictors will be evaluated in each group and their influence on occurrence of these adverse outcomes:
Echocardiographic data:
- RV systolic function by TAPSE and FAC on 2D-TTE.
- LV systolic function by m-mode on 2D-TTE.
- LV diastolic function on 2D-TTE.
- Estimated PASP on 2D-TTE.
- ASD shape on 3D-TEE.
- ASD maximal diameter on 3D-TEE.
- ASD minimal diameter on 3D-TEE.
- ASD area on 3D-TEE.
- Size of implanted device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with residual shunt | – | Radiation: ASD device closurepatient with residual left to right shunt detected by 2D-TTE at 6 month follow up after ASD device closure guided by 3D-TEE |
| patients without residual shunt | – | Radiation: ASD device closurepatient without residual left to right shunt by 2D-TTE at 6 month follow up after ASD device closure guided by 3D-TEE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with secundum atrial septal defect with suitable rims for transcatheter device closure
Key inclusion criteria (6 listed)
- Patients with suitable indication for ASD closure according to recent guidelines :
- Patients with isolated secundum ASD with sufficient rims suitable for device closure.
Key exclusion criteria (8 listed)
- Small ASD with Qp/Qs <1.5:1 or no signs of RV volume overload
- A single defect too large for closure (>38 mm)
- Multiple ASDs unsuitable for percutaneous closure.
- Anterior, posterior, superior, or inferior rim <5 mm.
- Abnormal pulmonary venous drainage.
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 |
|---|---|---|
| ASD device closuretranscatheter secundum ASD device closure | Radiation | patients with residual shunt, patients without residual shunt |
Primary outcome
Detection of residual shunt, MR deterioration and new onset AF following 3D-TEE guided ASD closure
Time frame: six months
Detection of residual shunt and MR deterioration by 2D-TTE and new-onset AF by ECG at six month follow up after ASD device closure
1 secondary outcome
Clinical outcomes after six months
Time frame: six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 30054146Alnasser S, Lee D, Austin PC, Labos C, Osten M, Lightfoot DT, Kutty S, Shah A, Meier L, Benson L, Horlick E. Long term outcomes among adults post transcatheter atrial septal defect closure: Systematic review and meta-analysis. Int J Cardiol. 2018 Nov 1;270:126-132. doi: 10.1016/j.ijcard.2018.06.076. Epub 2018 Jul 12.
- Background: PubMed 28390741Villablanca PA, Briston DA, Rodes-Cabau J, Briceno DF, Rao G, Aljoudi M, Shah AM, Mohananey D, Gupta T, Makkiya M, Ramakrishna H, Garcia MJ, Pass RH, Peek G, Zaidi AN. Treatment options for the closure of secundum atrial septal defects: A systematic review and meta-analysis. Int J Cardiol. 2017 Aug 15;241:149-155. doi: 10.1016/j.ijcard.2017.03.073. Epub 2017 Mar 24.
- Background: PubMed 26239900Silvestry FE, Cohen MS, Armsby LB, Burkule NJ, Fleishman CE, Hijazi ZM, Lang RM, Rome JJ, Wang Y; American Society of Echocardiography; Society for Cardiac Angiography and Interventions. Guidelines for the Echocardiographic Assessment of Atrial Septal Defect and Patent Foramen Ovale: From the American Society of Echocardiography and Society for Cardiac Angiography and Interventions. J Am Soc Echocardiogr. 2015 Aug;28(8):910-58. doi: 10.1016/j.echo.2015.05.015. No abstract available.
- Background: PubMed 11897451Chessa M, Carminati M, Butera G, Bini RM, Drago M, Rosti L, Giamberti A, Pome G, Bossone E, Frigiola A. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol. 2002 Mar 20;39(6):1061-5. doi: 10.1016/s0735-1097(02)01711-4.
- Background: PubMed 1858633Rao PS, Langhough R. Relationship of echocardiographic, shunt flow, and angiographic size to the stretched diameter of the atrial septal defect. Am Heart J. 1991 Aug;122(2):505-8. doi: 10.1016/0002-8703(91)91008-b.
- Background: PubMed 21677801Gupta SK, Sivasankaran S, Bijulal S, Tharakan JM, Harikrishnan S, Ajit K. Trans-catheter closure of atrial septal defect: Balloon sizing or no Balloon sizing - single centre experience. Ann Pediatr Cardiol. 2011 Jan;4(1):28-33. doi: 10.4103/0974-2069.79619.
- BackgroundKong WK. The relation between atrial septal defect area, diameter and shape using balloon sizing and three-dimensional transoesophageal echocardiography during percutaneous closure using occlutech device. Journal of the American College of Cardiology. 2017;69(11 Supplement):1493.
- Background: PubMed 25589703Scacciatella P, Marra S, Pullara A, Conrotto F, Marchetti M, Ferraro G, Pavani M, Biasco L, Bongiovanni D, Gaita F, Orzan F. Percutaneous closure of atrial septal defect in adults: very long-term clinical outcome and effects on aortic and mitral valve function. J Invasive Cardiol. 2015 Jan;27(1):65-9.
- BackgroundAkagi T, Fujii Y, Takaya Y, Takahashi S, et al. Clinical benefit of transcatheter closure for newly developed atrial fibrillation in adult patients with atrial septal defect. Journal of the American College of Cardiology. 2018;71(11):A549.
- Background: PubMed 26026868Takaya Y, Kijima Y, Akagi T, Nakagawa K, Oe H, Taniguchi M, Sano S, Ito H. Fate of Mitral Regurgitation After Transcatheter Closure of Atrial Septal Defect in Adults. Am J Cardiol. 2015 Aug 1;116(3):458-62. doi: 10.1016/j.amjcard.2015.04.042. Epub 2015 May 7.
- Background: PubMed 30121239Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Apr 2;73(12):e81-e192. doi: 10.1016/j.jacc.2018.08.1029. Epub 2018 Aug 16. No abstract available.
- Background: PubMed 25559473Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
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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. This study is not recruiting at the moment.
Mohamed Mousa principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of ASD2(Secundum Atrial Septal Defect), run by Assiut University.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 21 Sep 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of residual shunt, MR deterioration and new onset AF following 3D-TEE guided ASD closure (time frame: six months). 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 NCT03867708, which also lists 16 linked publications.
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 21 Sep 2020.