Septal Defect, AtrialPhase 3iASDNCT04395027
Iatrogenic Atrial Septal Defect Study (iASD)
A Phase 3 study testing atrial septal defect closure in people with Septal Defect, Atrial, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septal Defect, Atrial
- What is being tested?
- atrial septal defect closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2020to 22 Mar 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 at the time of informed consent signature.
- Capable of complying with Protocol requirements, including follow-up.
- An Informed Consent Form signed by Subject or legal representative.
- Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.
Who cannot join
- Remaining mitral regurgitation of ≥ moderate-severe
- Subject unable or unwilling to provide informed consent
- Concomitant severe aortic valve disease
- Dialysis
- Pregnancy or intent to become pregnant
- Life expectancy < 1 year
- Active bleeding
- Inability to follow up with 6-month timepoint due logistical concerns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iatrogenic Atrial Septal Defect Study
This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.
Read the detailed description
This study is an open label, prospective, multicenter, non-randomized single-arm study to evaluate the safety and efficacy of the closing iatrogenic atrial septal defects in patients undergoing transcatheter mitral valve procedures using large sheaths.
A maximum of 5 Clinical Sites (referred to as "Sites" in the remainder of this document) in the U.S. Two hundred and ten patients will be enrolled in this study. The patients will randomized 1:2 device: control. The anticipated accrual rate is approximately 20 Subjects per month for a total accrual period of approximately 12-18 months.
Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30 days, 6 months, and 12 months.
- Conditions
- Septal Defect, Atrial
- Being tested
- atrial septal defect closure
- Keywords
- mitral valve intervention, iatrogenic septal defect
- 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.
atrial septal defect closureDevice
The iatrogenic septal defect will be closed in the usual manner
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | These patients will not have their iatrogenic septal defect closed. |
| Device | Experimental | These patients will have their iatrogenic septal defect closed after the mitral intervention is completed. Receives: Device: atrial septal defect closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Survival at 6 months
Measured: 6 month
Secondary outcomes (3)
survival
survival at 1 year
Measured: 1 year
Freedom from heart failure hospitalization
Heart failure hospitalizations at 1 year
Measured: 1 year
NYHA Functional Class
Symptom status at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start6 May 2020
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Why it stopped: Administratively closed with IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septal Defect, AtrialStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiberio Frisoli, Henry Ford Health System
- Investigators
- Marvin Eng, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395027
- Sponsor's protocol ID
- 13708
- Acronym
- iASD
- Status last verified
- Dec 2022
- First submitted
- 15 May 2020
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iatrogenic Atrial Septal Defect Study
- ClinicalTrials.gov ID
- NCT04395027
- Acronym / sponsor ID
- iASD / 13708
- Conditions
- Septal Defect, Atrial
- Keywords
- mitral valve intervention, iatrogenic septal defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administratively closed with IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 20 May 2020 (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.
This is an open-label, randomized, controlled trial of iatrogenic atrial septal defect closure with the an atrial septal occluder versus usual care observation in patients post-mitral valve intervention requiring large bore transspetal access.
Detailed description
This study is an open label, prospective, multicenter, non-randomized single-arm study to evaluate the safety and efficacy of the closing iatrogenic atrial septal defects in patients undergoing transcatheter mitral valve procedures using large sheaths.
A maximum of 5 Clinical Sites (referred to as "Sites" in the remainder of this document) in the U.S. Two hundred and ten patients will be enrolled in this study. The patients will randomized 1:2 device: control. The anticipated accrual rate is approximately 20 Subjects per month for a total accrual period of approximately 12-18 months.
Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30 days, 6 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –These patients will not have their iatrogenic septal defect closed. |
| Device | Experimental | Device: atrial septal defect closureThese patients will have their iatrogenic septal defect closed after the mitral intervention is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 at the time of informed consent signature.
- Capable of complying with Protocol requirements, including follow-up.
- An Informed Consent Form signed by Subject or legal representative.
- Patient has had successful reduction of mitral regurgitation to at most moderate regurgitation post-mitral-clip.
Key exclusion criteria (8 listed)
- Remaining mitral regurgitation of ≥ moderate-severe
- Subject unable or unwilling to provide informed consent
- Concomitant severe aortic valve disease
- Dialysis
- Pregnancy or intent to become pregnant
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 |
|---|---|---|
| atrial septal defect closureThe iatrogenic septal defect will be closed in the usual manner | Device | Device |
Primary outcome
survival
Time frame: 6 month
Survival at 6 months
3 secondary outcomes
survival
Time frame: 1 year
Freedom from heart failure hospitalization
Time frame: 1 year
NYHA Functional Class
Time frame: 1 year
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 8 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Marvin Eng, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atrial septal defect closure in people with Septal Defect, Atrial, run by Henry Ford Health System at 1 site in United States.
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 4 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 8 Dec 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
survival (time frame: 6 month). 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 8 Dec 2022.