EchocardiographyNCT05321849
Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure
An observational study of Echocardiography and PDA, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial summary
Since the first successful percutaneous closure under transoesophageal echocardiographic (TEE) guidance, many centres explored transcatheter procedures without fluoroscopy. This single centre study aims to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Echocardiography, PDA
- What is being tested?
- Echocardiography guide
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Mar 2019to 23 Jun 2020
- How long will I take part?
- 5 Years
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The inclusion criteria for this study are children under 18 years old with PDA who were planned for PDA closure. The exclusion criteria include the coexistence of other associated congenital heart disease requiring surgical intervention and PDA patients with irreversible high pulmonary vascular resistance (PVR) unreactive with the oxygen test.
Who may be able to join
- PDA, age <= 18yo
Who cannot join
- >= 18yo, Eisenmenger syndrome, coexistence of other associated congenital heart disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita Jakarta Indonesia
Jakarta, 11420
About this study
Official title: Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure: A One-Year Single Centre Experience in Indonesia
Since the first successful percutaneous closure under transoesophageal echocardiographic (TEE) guidance, many centres explored transcatheter procedures without fluoroscopy. This single centre study aims to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under echocardiography-only guidance during our one-year experience. Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or echocardiography-only in National Cardiovascular Center Harapan Kita. Patients were evaluated clinically and radiologically using TTE at 6, 24 and 48 hours after the procedure. Primary endpoint was the procedural success. Secondary endpoints were the procedural time and the rate of adverse events. Echocardiography-guided PDA closure is non-inferior to fluoroscopy-guided PDA closure, with similar procedural times. However, this method is operator-dependent and requires an experienced team for it to be performed successfully.
Read the detailed description
From March 2019 to April 2020, a total of 60 patients with PDA were recruited as participants for this prospective, single-centre, non-randomized clinical trial. They were divided equally into two groups: the fluoroscopy group who underwent percutaneous PDA guided by fluoroscopy and the echocardiography group who underwent percutaneous PDA closures guided by transthoracic echocardiography (TTE) and TEE at the National Cardiovascular Centre Harapan Kita, Jakarta, Indonesia. Patients with stable hemodynamic and clinically asymptomatic PDA were evaluated and considered for transcatheter PDA closure. Significant chamber enlargement and mild to moderate pulmonary hypertension were also indications for transcatheter closure. Ductal morphology was evaluated using multiplanar TTE and TEE imaging.
After the procedures, patients were evaluated and followed-up after 6, 24 and 48 hours to observe any residual shunts and complications. This study protocol conforms to the ethical guidelines of the Declaration of Helsinki and the Nuremberg Code with approval from the Research Ethics Committee of National Cardiovascular Center Harapan Kita No LB.02.01/VII/475/KEP076/2020. Written consent to perform the procedure and to use the patients' medical records for this study was obtained from the patients or their parents.
- Conditions
- Echocardiography, PDA
- Being tested
- Echocardiography guide
- Keywords
- Patent Ductus Arteriosus (PDA), Transcatheter closure, Without fluoroscopy, echocardiography
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography guideOther
Patients with PDA are percutaneously closed with echocardiography guide, without fluoroscopy like classical procedures
| Study group | Role | What they receive |
|---|---|---|
| Use Fluoroscopy (Control) | PDA closure in 30 patients with fluoroscopy guide | |
| No fluoroscopy (test) | PDA closure in 30 patients with echocardiography guide, without fluoroscopy Receives: Other: Echocardiography guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours
PDA residual shunt post PDA closure
Measured: 6, 24 hours, and 48 hours
Change of Device Position from post-procedure to 6 hours, 24 hours and 48 hours
If device dislodge during follow-up
Measured: 6, 24 hours, and 48 hours
Secondary outcomes (2)
Procedural time
Time total needed to complete procedure
Measured: 6hours
Complication
if any death, peripheral vascular injury, pericardial effusion, pericardial tamponade
Measured: 6, 24hours, and 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start12 Mar 2019
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
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 EchocardiographyStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sisca Natalia Siagian, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Sisca N Siagian, MD, Principal investigator, National CCHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321849
- Sponsor's protocol ID
- LB.02.01/VII/475/KEP076/
- Status last verified
- Apr 2022
- First submitted
- 22 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment, we have no plan to share the whole participant data. However, if it is needed, we will.
Publications
Siagian SN, Prakoso R, Putra BE, Kurniawati Y, Lelya O, Sembiring AA, Atmosudigdo IS, Roebiono PS, Rahajoe AU, Harimurti GM, Mendel B, Christianto C, Setiawan M, Lilyasari O. Echocardiography-Guided Percutaneous Patent Ductus Arteriosus Closure: 1-Year Single Center Experience in Indonesia. Front Cardiovasc Med. 2022 May 23;9:885140. doi: 10.3389/fcvm.2022.885140. eCollection 2022.
PubMed 35677684
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure: A One-Year Single Centre Experience in Indonesia
- ClinicalTrials.gov ID
- NCT05321849
- Acronym / sponsor ID
- LB.02.01/VII/475/KEP076/
- Conditions
- Echocardiography, PDA
- Keywords
- Patent Ductus Arteriosus (PDA), Transcatheter closure, Without fluoroscopy, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 11 Apr 2022 (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.
Since the first successful percutaneous closure under transoesophageal echocardiographic (TEE) guidance, many centres explored transcatheter procedures without fluoroscopy. This single centre study aims to show the feasibility and safety of percutaneous patent ductus arteriosus (PDA) closure under echocardiography-only guidance during our one-year experience. Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or echocardiography-only in National Cardiovascular Center Harapan Kita. Patients were evaluated clinically and radiologically using TTE at 6, 24 and 48 hours after the procedure. Primary endpoint was the procedural success. Secondary endpoints were the procedural time and the rate of adverse events. Echocardiography-guided PDA closure is non-inferior to fluoroscopy-guided PDA closure, with similar procedural times. However, this method is operator-dependent and requires an experienced team for it to be performed successfully.
Detailed description
From March 2019 to April 2020, a total of 60 patients with PDA were recruited as participants for this prospective, single-centre, non-randomized clinical trial. They were divided equally into two groups: the fluoroscopy group who underwent percutaneous PDA guided by fluoroscopy and the echocardiography group who underwent percutaneous PDA closures guided by transthoracic echocardiography (TTE) and TEE at the National Cardiovascular Centre Harapan Kita, Jakarta, Indonesia. Patients with stable hemodynamic and clinically asymptomatic PDA were evaluated and considered for transcatheter PDA closure. Significant chamber enlargement and mild to moderate pulmonary hypertension were also indications for transcatheter closure. Ductal morphology was evaluated using multiplanar TTE and TEE imaging.
After the procedures, patients were evaluated and followed-up after 6, 24 and 48 hours to observe any residual shunts and complications. This study protocol conforms to the ethical guidelines of the Declaration of Helsinki and the Nuremberg Code with approval from the Research Ethics Committee of National Cardiovascular Center Harapan Kita No LB.02.01/VII/475/KEP076/2020. Written consent to perform the procedure and to use the patients' medical records for this study was obtained from the patients or their parents.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use Fluoroscopy (Control) | – | –PDA closure in 30 patients with fluoroscopy guide |
| No fluoroscopy (test) | – | Other: Echocardiography guidePDA closure in 30 patients with echocardiography guide, without fluoroscopy |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The inclusion criteria for this study are children under 18 years old with PDA who were planned for PDA closure. The exclusion criteria include the coexistence of other associated congenital heart disease requiring surgical intervention and PDA patients with irreversible high pulmonary vascular resistance (PVR) unreactive with the oxygen test.
Key inclusion criteria (1 listed)
- PDA, age <= 18yo
Key exclusion criteria (1 listed)
- >= 18yo, Eisenmenger syndrome, coexistence of other associated congenital heart disease
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 |
|---|---|---|
| Echocardiography guidePatients with PDA are percutaneously closed with echocardiography guide, without fluoroscopy like classical procedures | Other | No fluoroscopy (test) |
Primary outcome
Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours
Time frame: 6, 24 hours, and 48 hours
PDA residual shunt post PDA closure
Change of Device Position from post-procedure to 6 hours, 24 hours and 48 hours
Time frame: 6, 24 hours, and 48 hours
If device dislodge during follow-up
2 secondary outcomes
Procedural time
Time frame: 6hours
Complication
Time frame: 6, 24hours, and 48hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 35677684Siagian SN, Prakoso R, Putra BE, Kurniawati Y, Lelya O, Sembiring AA, Atmosudigdo IS, Roebiono PS, Rahajoe AU, Harimurti GM, Mendel B, Christianto C, Setiawan M, Lilyasari O. Echocardiography-Guided Percutaneous Patent Ductus Arteriosus Closure: 1-Year Single Center Experience in Indonesia. Front Cardiovasc Med. 2022 May 23;9:885140. doi: 10.3389/fcvm.2022.885140. eCollection 2022.
- Individual participant dataSharing planned: No. At the moment, we have no plan to share the whole participant data. However, if it is needed, we will.
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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.
Sisca N Siagian, MD principal investigator
National CCHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography and PDA, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
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 1 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: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours (time frame: 6, 24 hours, and 48 hours). The study lists 2 primary outcomes in all. 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 NCT05321849, 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 11 Apr 2022.