Multicenter other clinical trial according to §47 (3) MPDG* for the follow-up of the efficacy and safety of the GORE® CARDIOFORM ASD Occluder for transcatheter closure in patients with atrial septal defect (ASD II)

Multicenter other clinical trial according to §47 (3) MPDG* for the follow-up of the efficacy and safety of the GORE® CARDIOFORM ASD Occluder for transcatheter closure in patients with atrial septal defect (ASD II) - GORE® CARDIOFORM ASDO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027240

Enrollment

120

Registered

2022-01-18

Start date

2022-03-31

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Documentation of medical data collected in clinical routine after closure of an ASD with a GORE® CARDIOFORM ASD Occluder for evaluation of data regarding safety and efficacy of the occluder.

Interventions

Group 1: Single-arm follow-up study, data collection during ASD closure with the GORE Cardioform ASD Occluder.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. body weight = 12 Kg 2. fluent knowledge of the German language (patient and legal guardian) 3. presence of a hemodynamically significant ASD II 4. presence of one or more defects to be occluded with a total of one GORE® CARDIOFORM ASD Occluder. 5. consent to participate in the other clinical trial 6. willingness to have the control examinations after 6 and 12 months (according to the clinical routine) performed in the treating clinic

Exclusion criteria

Exclusion criteria: 1. presence of multiple defects that cannot be closed with a GORE® CARDIOFORM ASD Occluder 2. simultaneous participation in a clinical trial with medical devices or drugs, which is not yet completed 3. presence of recent myocardial infarction, unstable angina or decompensated heart failure 4. presence of active bacterial and/or viral infection 5. evidence of intracardiac thrombi on echocardiography

Design outcomes

Primary

Measure	Time frame
Efficacy and safety especially in defects with little or no aortic rim. This is defined as successful placement of the occluder and successful closure of the defect without severe complications (such as occluder embolism, surgical reintervention, moderate or large residual shunt, new-onset AV block grade II or grade III) on the day of discharge.	—

Secondary

Measure	Time frame
Efficacy and safety at 6 and 12 months after the procedure, defined as stable occluder position and no serious complications during the follow-up period (such as occluder embolism, erosions, surgical reintervention, moderate or large residual shunt, new-onset arrhythmias, AV block grade II or grade III).	—

Countries

Germany

Contacts

Public ContactAndrea Engelhardt

Deutsches Herzzentrum München TUM Universitätsklinikum, Klinik für angeborene Herzfehler und Kinderkardiologie, Studienzentrum

PM.GORE.Cardioform.ASDO@dhm.mhn.de089-1218-1658

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026