Transcatheter Exclusion of Atrial-septal-aneurysm (TEA) (TEA)

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Septal Aneurysm
• Intervention / Treatment: Device: Transcatheter exclusion of atrial septal aneurysm

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chaowu Yan, PhD and MD; Phone Number: +861088398408; Email: chaowuyan@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Yan Chaowu
      • Contact: Chaowu Yan, PhD and MD; Phone Number: +861088398408; Email: chaowuyan@163.com
      • Principal Investigator: Chaowu Yan, PhD and MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter exclusion of atrial septal aneurysm; Transcatheter reconstruction of atrial septum might be achieved with PFO occluder through transseptal perforation in patients with ASA.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Chaowu Yan, PhD and MD, National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 20, 2020
• First Submitted That Met QC Criteria: September 20, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: atrial septal aneurysm; patent foramen ovale; defect; stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: 2020-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No