Atrial Septal Defect (ASD)NCT06655935
Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience
A study testing Ordinary Transcatheter ASD closure and modified transcatheter ASD closure in people with Atrial Septal Defect (ASD), run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. In this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Atrial Septal Defect (ASD)
- What is being tested?
- Ordinary Transcatheter ASD closure and modified transcatheter ASD closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Jun 2023
- Phase
- Interventional
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient with ostium secundum ASD \& RV volume overload
Who cannot join
- Any other type of atrial septal defects Any other associated congenital anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. In this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease complication rate.
Read the detailed description
Delivery sheath can be advanced over multipurpose catheter instead of stiff wire
- Conditions
- Atrial Septal Defect (ASD)
- Being tested
- Ordinary Transcatheter ASD closure, modified transcatheter ASD closure
- Keywords
- atrial septal defects, transcatheter closure, modified technique
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ordinary Transcatheter ASD closureProcedure or surgery
deploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO inside the left atrial cavity over stiff wire into the pulmonary veins
modified transcatheter ASD closureProcedure or surgery
deploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO over the multipurpose catheter inside the left atrial cavity which might help in the shortage of the duration \& the cost of the procedure with less complication rate
| Study group | Role | What they receive |
|---|---|---|
| 44 patients with ASD who underwent the ordinary transcatheter closure technique using ASO. | Active comparator | The dilator of the Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over stiff wire into the pulmonary veins Receives: Procedure: Ordinary Transcatheter ASD closure |
| 36 patients with ASD who underwent the modified transcatheter closure technique using ASO | Experimental | Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over the multipurpose catheter to the left atrial cavity Receives: Procedure: modified transcatheter ASD closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
recording any complication during transcatheter secundum atrial septal defect closure
stiff wire can cause perforation or arrhythmias
Measured: during the procedure
Secondary outcomes (1)
assess the duration of the procedure and if this affects the cost of the procedure by any means
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Jun 2022
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal Defect (ASD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Nouran Mostafa Mansour, Egyptian Biomedical Research Network
- Investigators
- Raghda El sheikh, professor, Study director, Cardiology departement-Tanta University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655935
- Sponsor's protocol ID
- 36264PR84/2/23
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: because of the confidentiality of the patients data
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience
- ClinicalTrials.gov ID
- NCT06655935
- Acronym / sponsor ID
- 36264PR84/2/23
- Conditions
- Atrial Septal Defect (ASD)
- Keywords
- atrial septal defects, transcatheter closure, modified technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Collaborators
- Tanta University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Oct 2024 (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.
Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. In this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease complication rate.
Detailed description
Delivery sheath can be advanced over multipurpose catheter instead of stiff wire
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 44 patients with ASD who underwent the ordinary transcatheter closure technique using ASO. | Active comparator | Procedure: Ordinary Transcatheter ASD closureThe dilator of the Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over stiff wire into the pulmonary veins |
| 36 patients with ASD who underwent the modified transcatheter closure technique using ASO | Experimental | Procedure: modified transcatheter ASD closureAmplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over the multipurpose catheter to the left atrial cavity |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with ostium secundum ASD \& RV volume overload
Key exclusion criteria (1 listed)
- Any other type of atrial septal defects Any other associated congenital anomaly
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 |
|---|---|---|
| Ordinary Transcatheter ASD closuredeploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO inside the left atrial cavity over stiff wire into the pulmonary veins | Procedure or surgery | 44 patients with ASD who underwent the ordinary transcatheter closure technique using ASO. |
| modified transcatheter ASD closuredeploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO over the multipurpose catheter inside the left atrial cavity which might help in the shortage of the duration \& the cost of the procedure with less complication rate | Procedure or surgery | 36 patients with ASD who underwent the modified transcatheter closure technique using ASO |
Primary outcome
recording any complication during transcatheter secundum atrial septal defect closure
Time frame: during the procedure
stiff wire can cause perforation or arrhythmias
1 secondary outcome
assess the duration of the procedure and if this affects the cost of the procedure by any means
Time frame: during the procedure
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 29 Oct 2024.
- Individual participant dataSharing planned: No. because of the confidentiality of the patients data
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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.
Raghda El sheikh, professor study director
Cardiology departement-Tanta University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ordinary Transcatheter ASD closure and modified transcatheter ASD closure in people with Atrial Septal Defect (ASD), run by Egyptian Biomedical Research Network at 1 site in Egypt.
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 29 Oct 2024. 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 Egypt. 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?
recording any complication during transcatheter secundum atrial septal defect closure (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2024.