CompletedNot Applicable

Trevisio Post-Approval Study

France254 participantsStarted 2020-09-14

Plain-language summary

A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient was indicated for implantation with the Amplatzer Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure) OR subject was indicated for implantation with the Amplatzer PFO Occluder
✓. Patient was of legal age and has provided his/her own written, informed consent
✓. Patient was indicated for implantation with the Amplatzer Muscular VSD Occluder OR patient was indicated for implantation with the Amplatzer Post-Infarct Muscular VSD Occluder

Exclusion criteria

✕. Presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Principal Investigator's opinion, could limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
✕. Exclusion Criteria for Patients Undergoing ASD Closure with the Amplatzer ASO or Amplatzer ASD-MF Occluder
✕. Exclusion Criteria for Patients Undergoing PFO Closure
✕. Body weight \<8 kg
✕. Tetralogy of Fallot
✕. Intracardiac thrombi on echocardiography

What they're measuring

Effectiveness Endpoint: Rate of Technical Success

Timeframe: at pre-hospital discharge or 7 days after the procedure

Safety Endpoint : Device- or Procedure-related Serious Adverse Events.

Timeframe: through discharge or 7 days after the procedure

Trial details

NCT IDNCT04433520

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-01-04

Results submitted2026-01-12

View on ClinicalTrials.gov More PFO - Patent Foramen Ovale trials