ASD - Atrial Septal Defect, PFO - Patent Foramen Ovale, PIVSD - Post Infarct Muscular Ventricular Septal Defect, VSD - Muscular Ventricular Septal Defect
Conditions
Keywords
ABT-CIP_10319, Amplatzer Trevisio Intravascular Delivery System, Amplatzer Occluder devices
Brief 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.
Interventions
DEVICEAmplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder.
DEVICEAmplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder.
Sponsors
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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 2. Patient was of legal age and has provided his/her own written, informed consent OR Patient was a minor and has provided verbal and/or written informed consent or assent per local EC requirements, and his/her legally authorized representative, or representatives, had provided written informed consent on behalf of the minor according to local EC requirements 3. 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
1. 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. 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Endpoint: Rate of Technical Success | at pre-hospital discharge or 7 days after the procedure | The Technical success, defined as successful deployment and release of at least one device |
| Safety Endpoint : Device- or Procedure-related Serious Adverse Events. | through discharge or 7 days after the procedure | The primary safety endpoint is device- or procedure-related serious adverse events through discharge or 7 days, whichever is earlier, including: * Cardiac perforation * Sustained atrial fibrillation requiring intervention * Device thrombus * Device erosion * Device embolization * Vascular complication requiring surgical intervention * Device- or procedure-related serious adverse event leading to death |
Countries
France, Germany, Italy, Netherlands, Poland, Spain, Switzerland
Contacts
STUDY_DIRECTORBarathi Sethuraman
DVP Global Clinical Affairs Structural Heart
Participant flow
Recruitment details
The study enrolled a total of 251 subjects in the ASD/PFO cohort at 22 investigational sites and total of 3 subjects in the VSD cohort enrolled at 3 investigational sites (all in Europe)
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized | 61 years |
| Hypertension | 2 Participants |
| Migraine | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 251 | 0 / 3 |
| other Total, other adverse events | 7 / 251 | 1 / 3 |
| serious Total, serious adverse events | 1 / 251 | 0 / 3 |
Outcome results
None listed