Ostium Secundum Atrial Septal DefectNCT02601768
Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment
An observational study of Ostium Secundum Atrial Septal Defect, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ostium Secundum Atrial Septal Defect
- What is being tested?
- Transcatheter closure of ASD II
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2015to Dec 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 50 consecutive adult patients with ASD II closed percutaneously in our center in the study time frame i.e.
Who may be able to join
- ASD II suitable for percutaneous treatment
- free and informed consent to analyze the medical data of the person concerned
- age: patients over 16
Who cannot join
- ASD II not suitable for percutaneous treatment
- any valvular heart disease requiring cardiac surgery
- no free and informed consent to analyze the medical data of the person concerned
- age: under 16
Trial locations and contacts
1 site in 1 country.
Marcin Demkow, Prof. MD PhD contact
Poland1 site, 1 recruiting
- Recruiting
Institute Of Cardiology
Warsaw, 04-628
Jan Henzel, MD, 223434342 ext. +48, jhenzel@ikard.pl
About this study
Official title: Occluder Size Determination in Transcatheter Closure of Ostium Secundum Atrial Septal Defect Based on Three-Dimensional Echocardiography Assessment
The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect.
Read the detailed description
A total of 50 consecutive patients eligible to percutaneous ASD II closure will be enrolled in the study. 3D-TEE will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. Traditional 2D-TEE together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. Control transthoracic echocardiography (TTE) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. The previously obtained 3D images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. Maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. Correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.
- Conditions
- Ostium Secundum Atrial Septal Defect
- Being tested
- Transcatheter closure of ASD II
- Keywords
- ASD II, transcatheter closure, percutaneous closure, 3D TEE, balloon-sizing
- 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.
Transcatheter closure of ASD IIDevice
Transcatheter closure of ASD II performed in our center.
| Study group | Role | What they receive |
|---|---|---|
| ASD II | Transcatheter closure of ASD II Receives: Device: Transcatheter closure of ASD II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the proposed and actual device size.
The correlation will be analyzed after the data of the whole group has been completed.
Measured: 18 months
Secondary outcomes (1)
Success rate of the procedure
Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostium Secundum Atrial Septal DefectStudies 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Henzel, MD, Study director, Institute Of Cardiology in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601768
- Sponsor's protocol ID
- 2.11/VI/15
- Status last verified
- Nov 2015
- First submitted
- 9 Nov 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occluder Size Determination in Transcatheter Closure of Ostium Secundum Atrial Septal Defect Based on Three-Dimensional Echocardiography Assessment
- ClinicalTrials.gov ID
- NCT02601768
- Acronym / sponsor ID
- 2.11/VI/15
- Conditions
- Ostium Secundum Atrial Septal Defect
- Keywords
- ASD II, transcatheter closure, percutaneous closure, 3D TEE, balloon-sizing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Nov 2015 (estimated)
- 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.
The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect.
Detailed description
A total of 50 consecutive patients eligible to percutaneous ASD II closure will be enrolled in the study. 3D-TEE will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. Traditional 2D-TEE together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. Control transthoracic echocardiography (TTE) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. The previously obtained 3D images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. Maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. Correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD II | – | Device: Transcatheter closure of ASD IITranscatheter closure of ASD II |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 consecutive adult patients with ASD II closed percutaneously in our center in the study time frame i.e.
Key inclusion criteria (3 listed)
- ASD II suitable for percutaneous treatment
- free and informed consent to analyze the medical data of the person concerned
- age: patients over 16
Key exclusion criteria (4 listed)
- ASD II not suitable for percutaneous treatment
- any valvular heart disease requiring cardiac surgery
- no free and informed consent to analyze the medical data of the person concerned
- age: under 16
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 closure of ASD IITranscatheter closure of ASD II performed in our center. | Device | ASD II |
Primary outcome
Correlation between the proposed and actual device size.
Time frame: 18 months
The correlation will be analyzed after the data of the whole group has been completed.
1 secondary outcome
Success rate of the procedure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
Related trials for Ostium Secundum Atrial Septal Defect
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ASD2(Secundum Atrial Septal Defect)
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Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
Heart Septal Defect, Heart Septal Defects, Atrial
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.
Marcin Demkow, Prof. MD PhD contact
Jan Henzel, MD study director
Institute Of Cardiology in Warsaw
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 Ostium Secundum Atrial Septal Defect, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Nov 2015. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Henzel, MD (600699211 ext. +48, jhenzel@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the proposed and actual device size. (time frame: 18 months). 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 10 Nov 2015.