NCT04561882

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

September 20, 2020

Last Update Submit

September 20, 2020

Conditions

Atrial Septal Aneurysm

Keywords

atrial septal aneurysm; patent foramen ovale; defect; stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Procedural or device complications

    12 months

  • Adverse event rates for all subjects

    12 months

Study Arms (1)

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.

Device: Transcatheter exclusion of atrial septal aneurysm

Interventions

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)

Transcatheter exclusion of atrial septal aneurysm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Acute infection or sepsis;
  • Intra-cardiac thrombus;
  • Carotid, vertebral or basilar artery stenosis \> 50% on duplex imaging;
  • Patients unable to grant informed, written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yan Chaowu

Beijing, Beijing Municipality, 100037, China

RECRUITING

Yan Chaowu

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, PatentStroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Chaowu Yan, PhD and MD

    National Center for Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaowu Yan, PhD and MD

CONTACT

+861088398408chaowuyan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2020

First Posted

September 24, 2020

Study Start

September 4, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)