Atrial Septal AneurysmTEANCT04561882
Transcatheter Exclusion of Atrial-septal-aneurysm (TEA)
A study testing Transcatheter exclusion of atrial septal aneurysm in people with Atrial Septal Aneurysm, run by China National Center for Cardiovascular Diseases at 2 sites in China.
Trial summary
This study aims to investigate the safety and efficacy of transcatheter exclusion of atrial septal aneurysm (ASA) via transseptal perforation in patients with ASA. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Septal Aneurysm
- What is being tested?
- Transcatheter exclusion of atrial septal aneurysm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesChina
- Study dates
- 4 Sep 2020to 1 Dec 2022
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In large-ASA patients with PFO (Phase1) (1)The length of ASA >20 mm and bulging >10 mm or a combined total excursion right and left > 15 mm; (2)Presence of a PFO indicated for device closure (Echocardiographic and/or transcranial Doppler evidence of right to left shunt at the atrial level); (3)History of cryptogenic stroke/TIA/migraine without other risks; (4) Failure to cover ASA after trial device-closure of PFO and the unstable device confirmed with push-pull test;
- In large-ASA patients with secundum ASD (Phase1) (1)The length of ASA >20 mm and bulging >15 mm or a combined total excursion right and left > 15 mm; (2)Secundum ASD with Qp/Qs>1.5 or echocardiographic evidence of right heart enlargement; (3)Failure to cover ASA after trial device-closure of ASD and the unstable device confirmed with push-pull test;
- Isolated ASA with high risk (Phase2) (1)History of migraine attacks/TIA/cryptogenic stroke without other risks in the last 6 months; (2)Thickening of ASA wall ≥ 5 mm; (3)Spontaneous echo contrast;
- Left atrial septal pouch (Phase3) (1)History of migraine attacks/TIA/cryptogenic stroke without other risks in the last 6 months; (2)Spontaneous echo contrast in left atrium;
Who cannot join
- Acute infection or sepsis;
- Intra-cardiac thrombus;
- Carotid, vertebral or basilar artery stenosis > 50% on duplex imaging;
- Patients unable to grant informed, written consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Yan Chaowu
Beijing, Beijing Municipality, 100037
Chaowu Yan, PhD and MD, +861088398408, chaowuyan@163.com
- Recruiting
Yan Chaowu
Beijing, Beijing Municipality, 100037
Chaowu Yan, PhD and MD, +861088398408, chaowuyan@163.com
Chaowu Yan, PhD and MD
About this study
Official title: Transcatheter Exclusion of Atrial Septal Aneurysm Via Transseptal Perforation: First-in-human Use Study
This study aims to investigate the safety and efficacy of transcatheter exclusion of atrial septal aneurysm (ASA) via transseptal perforation in patients with ASA.
Read the detailed description
Atrial septal aneurysm (ASA) has been considered a potential cardiac source of embolism, and its prevalence is about 1%. In adult patients with stroke and normal carotid arteries, ASA is an important predictor of recurrent stroke. The most common abnormalities associated are interatrial shunts, that is, a patent foramen ovale (PFO) or an atrial septal defect (ASD). For large ASA with interatrial shunt, it is difficult to cover ASA with conventional devices, which might result in unstability of occluders and related complications . For isolated ASA with high risk, thrombus and emboli have been reported and anticoagulation has been used empirically.
In addition, the left atrial septal pouch can be considered as a special subtype of atrial septal aneurysm, in which thrombus might arise from the cavity of the pouch. Pervious researches have noted that left atrial septal pouch was a site of origin of thrombus formation and a source of embolism, and it was associated with cryptogenic stroke. For patients with ASA, we hypothesizes that transcatheter reconstruction of atrial septum might be achieved with PFO occluder through transseptal perforation. The aim of this study is to investigate the safety and efficacy of transcatheter exclusion of ASA via transseptal perforation.
This study will enroll subjects with ASA (including left atrial septal pouch), and enrollment will be divided into three phases.
Phase 1: large ASA patients with interatrial communication (ASD or PFO). A maximum of 30 patients is reached.
Phase 2: ASA patients with intact septum and high risk of cryptogenic stroke. A maximum of 20 patients is reached.
Phase 3: left atrial septal pouch with high risk of cryptogenic stroke. A maximum of 20 patients is reached.
- Conditions
- Atrial Septal Aneurysm
- Being tested
- Transcatheter exclusion of atrial septal aneurysm
- Keywords
- atrial septal aneurysm; patent foramen ovale; defect; stroke
- Medical subject headings
- Foramen Ovale, Patent, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter exclusion of atrial septal aneurysmDevice
Through transseptal perforation, transcatheter reconstruction of atrial septum was achieved with PFO occluder to cover the whole ASA.
Device: Cardi-O-Fix™ patent foramen ovale occluder (Starway Medical Technology, Inc. Beijing, CN)
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter exclusion of atrial septal aneurysm | Experimental | Transcatheter reconstruction of atrial septum might be achieved with PFO occluder through transseptal perforation in patients with ASA. Receives: Device: Transcatheter exclusion of atrial septal aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with effective exclusion of ASA
Assessment of ASA exclusion by echocardiography/MSCT during follow-up. Effective exclusion of ASA was defined as complete coverage of whole ASA.
Measured: 12 months
Secondary outcomes (2)
Procedural or device complications
Procedural or device complications during follow-up
Measured: 12 months
Adverse event rates for all subjects
including migraine (severity, frequency and duration with or without aura), TIA, ischemic stroke or systemic embolism.
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 posted24 Sep 2020
- Study start4 Sep 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal AneurysmStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chaowu Yan, PhD and MD, Principal investigator, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561882
- Sponsor's protocol ID
- 2020-7
- Acronym
- TEA
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Exclusion of Atrial Septal Aneurysm Via Transseptal Perforation: First-in-human Use Study
- ClinicalTrials.gov ID
- NCT04561882
- Acronym / sponsor ID
- TEA / 2020-7
- Conditions
- Atrial Septal Aneurysm
- Keywords
- atrial septal aneurysm; patent foramen ovale; defect; stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Sep 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 study aims to investigate the safety and efficacy of transcatheter exclusion of atrial septal aneurysm (ASA) via transseptal perforation in patients with ASA.
Detailed description
Atrial septal aneurysm (ASA) has been considered a potential cardiac source of embolism, and its prevalence is about 1%. In adult patients with stroke and normal carotid arteries, ASA is an important predictor of recurrent stroke. The most common abnormalities associated are interatrial shunts, that is, a patent foramen ovale (PFO) or an atrial septal defect (ASD). For large ASA with interatrial shunt, it is difficult to cover ASA with conventional devices, which might result in unstability of occluders and related complications . For isolated ASA with high risk, thrombus and emboli have been reported and anticoagulation has been used empirically.
In addition, the left atrial septal pouch can be considered as a special subtype of atrial septal aneurysm, in which thrombus might arise from the cavity of the pouch. Pervious researches have noted that left atrial septal pouch was a site of origin of thrombus formation and a source of embolism, and it was associated with cryptogenic stroke. For patients with ASA, we hypothesizes that transcatheter reconstruction of atrial septum might be achieved with PFO occluder through transseptal perforation. The aim of this study is to investigate the safety and efficacy of transcatheter exclusion of ASA via transseptal perforation.
This study will enroll subjects with ASA (including left atrial septal pouch), and enrollment will be divided into three phases.
Phase 1: large ASA patients with interatrial communication (ASD or PFO). A maximum of 30 patients is reached.
Phase 2: ASA patients with intact septum and high risk of cryptogenic stroke. A maximum of 20 patients is reached.
Phase 3: left atrial septal pouch with high risk of cryptogenic stroke. A maximum of 20 patients is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter exclusion of atrial septal aneurysm | Experimental | Device: Transcatheter exclusion of atrial septal aneurysmTranscatheter reconstruction of atrial septum might be achieved with PFO occluder through transseptal perforation in patients with ASA. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In large-ASA patients with PFO (Phase1) (1)The length of ASA >20 mm and bulging >10 mm or a combined total excursion right and left > 15 mm; (2)Presence of a PFO indicated for device closure (Echocardiographic and/or transcranial Doppler evidence of right to left shunt at the atrial level); (3)History of cryptogenic stroke/TIA/migraine without other risks; (4) Failure to cover ASA after trial device-closure of PFO and the unstable device confirmed with push-pull test;
- In large-ASA patients with secundum ASD (Phase1) (1)The length of ASA >20 mm and bulging >15 mm or a combined total excursion right and left > 15 mm; (2)Secundum ASD with Qp/Qs>1.5 or echocardiographic evidence of right heart enlargement; (3)Failure to cover ASA after trial device-closure of ASD and the unstable device confirmed with push-pull test;
- Isolated ASA with high risk (Phase2) (1)History of migraine attacks/TIA/cryptogenic stroke without other risks in the last 6 months; (2)Thickening of ASA wall ≥ 5 mm; (3)Spontaneous echo contrast;
- Left atrial septal pouch (Phase3) (1)History of migraine attacks/TIA/cryptogenic stroke without other risks in the last 6 months; (2)Spontaneous echo contrast in left atrium;
Key exclusion criteria (4 listed)
- Acute infection or sepsis;
- Intra-cardiac thrombus;
- Carotid, vertebral or basilar artery stenosis > 50% on duplex imaging;
- Patients unable to grant informed, written consent.
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 exclusion of atrial septal aneurysmThrough transseptal perforation, transcatheter reconstruction of atrial septum was achieved with PFO occluder to cover the whole ASA. Device: Cardi-O-Fix™ patent foramen ovale occluder (Starway Medical Technology, Inc. Beijing, CN) | Device | Transcatheter exclusion of atrial septal aneurysm |
Primary outcome
Number of subjects with effective exclusion of ASA
Time frame: 12 months
Assessment of ASA exclusion by echocardiography/MSCT during follow-up. Effective exclusion of ASA was defined as complete coverage of whole ASA.
2 secondary outcomes
Procedural or device complications
Time frame: 12 months
Adverse event rates for all subjects
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 24 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Atrial Septal Aneurysm
RecruitingPhase 3
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Cryptogenic Ischemic Stroke, Patent Foramen Ovale
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.
Chaowu Yan, PhD and MD principal investigator
National Center for Cardiovascular Diseases
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter exclusion of atrial septal aneurysm in people with Atrial Septal Aneurysm, run by China National Center for Cardiovascular Diseases at 2 sites in China.
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 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 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Chaowu Yan, PhD and MD (+861088398408, chaowuyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with effective exclusion of ASA (time frame: 12 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 24 Sep 2020.