Transcatheter Exclusion of Atrial-septal-aneurysm (TEA)

Atrial Septal Aneurysm Clinical Trial

— TEA  

Official title:

Transcatheter Exclusion of Atrial Septal Aneurysm Via Transseptal Perforation: First-in-human Use Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561882
• Other study ID #: 2020-7
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2020
• Source: China National Center for Cardiovascular Diseases
• Contact: Chaowu Yan, PhD and MD
• Phone: +861088398408
• Email: chaowuyan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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;

3. 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;

4. 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;

Exclusion Criteria:

1. Acute infection or sepsis;

2. Intra-cardiac thrombus;

3. Carotid, vertebral or basilar artery stenosis > 50% on duplex imaging;

4. Patients unable to grant informed, written consent.

Related Conditions & MeSH terms

• Aneurysm
• Atrial Septal Aneurysm

Intervention

Device:
• Transcatheter exclusion of atrial septal aneurysm
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)

Locations

Country	Name	City	State
China	Yan Chaowu	Beijing	Beijing
China	Yan Chaowu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Procedural or device complications	Procedural or device complications during follow-up	12 months
Secondary	Adverse event rates for all subjects	including migraine (severity, frequency and duration with or without aura), TIA, ischemic stroke or systemic embolism.	12 months