Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment

• Register: ClinicalTrials.gov
• Last refreshed on: 23 November 2015
• Main ID: NCT02601768
• Date of registration: 09/11/2015
• Prospective Registration: No
• Primary sponsor: Institute of Cardiology, Warsaw, Poland
• Public title: Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment
• Scientific title: Occluder Size Determination in Transcatheter Closure of Ostium Secundum Atrial Septal Defect Based on Three-Dimensional Echocardiography Assessment
• Date of first enrolment: January 2015
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02601768
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

Poland

Contacts

• Name: Jan Henzel, MD

• Name: Jan Henzel, MD
• Affiliation: Institute Of Cardiology in Warsaw

• Name: Jan Henzel, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- ASD II suitable for percutaneous treatment

- free and informed consent to analyze the medical data of the person concerned

- age: patients over 16

Exclusion Criteria:

- ASD II not suitable for percutaneous treatment

- any valvular heart disease requiring cardiac surgery

- no free and informed consent to analyze the medical data of the person concerned

- age: under 16



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ostium Secundum Atrial Septal Defect

Intervention(s)

Device: Transcatheter closure of ASD II

Primary Outcome(s)

Correlation between the proposed and actual device size. [Time Frame: 18 months]

Secondary Outcome(s)

Success rate of the procedure [Time Frame: 12 months]

Secondary ID(s)

2.11/VI/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors