Trial Outcomes & Findings for Trevisio Post-Approval Study (NCT NCT04433520)
NCT ID: NCT04433520
Last Updated: 2026-03-16
Results Overview
The Technical success, defined as successful deployment and release of at least one device
Recruitment status
COMPLETED
Target enrollment
254 participants
Primary outcome timeframe
at pre-hospital discharge or 7 days after the procedure
Results posted on
2026-03-16
Participant Flow
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)
Participant milestones
| Measure |
ASD/PFO Cohort
Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
The Amplatzer Trevisio Delivery System is to be used for facilitating percutaneous, transcatheter implantation of the occluders.
Device: Amplatzer™ 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.
|
VSD Cohort
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
Device: Amplatzer™ 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.
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
3
|
|
Overall Study
COMPLETED
|
251
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ASD/PFO Cohort
n=251 Participants
Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
The Amplatzer Trevisio Delivery System is to be used for facilitating percutaneous, transcatheter implantation of the occluders.
Device: Amplatzer™ 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.
|
VSD Cohort
n=3 Participants
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
Device: Amplatzer™ 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.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
45 years
n=251 Participants
|
77 years
n=3 Participants
|
61 years
n=254 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=251 Participants
|
1 Participants
n=3 Participants
|
130 Participants
n=254 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=251 Participants
|
2 Participants
n=3 Participants
|
124 Participants
n=254 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Migraine
|
41 Participants
n=251 Participants
|
0 Participants
n=3 Participants
|
41 Participants
n=254 Participants
|
|
Hypertension
|
NA Participants
n=251 Participants
|
2 Participants
n=3 Participants
|
NA Participants
n=254 Participants
|
PRIMARY outcome
Timeframe: at pre-hospital discharge or 7 days after the procedurePopulation: The endpoint analysis was performed on the Attempted Procedure (AP) population
The Technical success, defined as successful deployment and release of at least one device
Outcome measures
| Measure |
ASD/PFO Cohort
n=251 Participants
Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
The Amplatzer Trevisio Delivery System is to be used for facilitating percutaneous, transcatheter implantation of the occluders.
Device: Amplatzer™ 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.
|
VSD Cohort
n=3 Participants
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
Device: Amplatzer™ 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.
|
|---|---|---|
|
Effectiveness Endpoint: Rate of Technical Success
|
247 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: through discharge or 7 days after the procedurePopulation: The endpoint analysis was performed on the Attempted Procedure (AP) population
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
Outcome measures
| Measure |
ASD/PFO Cohort
n=251 Participants
Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
The Amplatzer Trevisio Delivery System is to be used for facilitating percutaneous, transcatheter implantation of the occluders.
Device: Amplatzer™ 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.
|
VSD Cohort
n=3 Participants
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
Device: Amplatzer™ 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.
|
|---|---|---|
|
Safety Endpoint : Device- or Procedure-related Serious Adverse Events.
|
1 Participants
|
0 Participants
|
Adverse Events
ASD/PFO Cohort
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
VSD Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ASD/PFO Cohort
n=251 participants at risk
Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
The Amplatzer Trevisio Delivery System is to be used for facilitating percutaneous, transcatheter implantation of the occluders.
Device: Amplatzer™ 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.
|
VSD Cohort
n=3 participants at risk
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
Device: Amplatzer™ 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.
|
|---|---|---|
|
Vascular disorders
Device embolization
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
Other adverse events
| Measure |
ASD/PFO Cohort
n=251 participants at risk
Subjects indicated for atrial septal defect (ASD) closure with either the ASO or ASD-MF devices as well as subjects indicated for patent foramen ovale (PFO) closure with the Amplatzer PFO Occluder.
The Amplatzer Trevisio Delivery System is to be used for facilitating percutaneous, transcatheter implantation of the occluders.
Device: Amplatzer™ 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.
|
VSD Cohort
n=3 participants at risk
Subjects indicated for ventricular septal defect (VSD) closure with either the MuscVSD or PIVSD occluders.
Device: Amplatzer™ 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.
|
|---|---|---|
|
Investigations
St Segment Changes
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
Nervous system disorders
Headache
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
Vascular disorders
Hematoma
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/251 • Pre-hospital discharge or 7 days after the procedure
|
33.3%
1/3 • Pre-hospital discharge or 7 days after the procedure
|
|
Cardiac disorders
Tachycardia
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
General disorders
Chest Pain
|
1.2%
3/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
General disorders
Pain In The Punctured Groin
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
General disorders
Vasc Bleeding
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
Injury, poisoning and procedural complications
Other Skin Changes
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
|
Investigations
Oxygen Saturation Decrease
|
0.40%
1/251 • Pre-hospital discharge or 7 days after the procedure
|
0.00%
0/3 • Pre-hospital discharge or 7 days after the procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator \& Sponsor that restricts PI's rights to discuss or publish trial results after its completion. Single-center results are not allowed to be published or presented before multi-center results. Any proposed publications or presentations from Investigators must be submitted to the Sponsor for review \& approval.This review must occur in a timely manner \& must follow the Sponsor's publication policies as outlined in the Clinical Trial Agreement.
- Publication restrictions are in place
Restriction type: OTHER