Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504121
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
PFO tRanscatether Occlusion Long-term Outcomes National Group PROLONG Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PFO tRanscatether Occlusion Long-term Outcomes National Group PROLONG Registry
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROLONG
Brief Summary:
Patent foramen ovale PFO has been associated with cryptogenic stroke and transient ischemic attack TIA in young adults
Evidence from randomized clinical trials RCT has shown that transcatheter PFO closure yields a 59 relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals
However the follow-up duration in these studies averaged around 4 years while only two studies report a median follow-up beyond 10 years Considering the relative youth of the patients undergoing this procedure average age being under 50 years across all studies we can reasonably anticipate a substantial post-PFO closure lifespan for these individuals Consequently it is imperative to gather more extensive long-term follow-up data among PFO closure recipients The PROLONG PFO tRanscatether Occlusion Long-term Outcomes National Group is an observational retrospective multicenter national registry including men and women undergoing transcatheter PFO closure with the aim of assessing the long-term 10 years efficacy and safety of this procedure
Evidence from randomized clinical trials RCT has shown that transcatheter PFO closure yields a 59 relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals
However the follow-up duration in these studies averaged around 4 years while only two studies report a median follow-up beyond 10 years Considering the relative youth of the patients undergoing this procedure average age being under 50 years across all studies we can reasonably anticipate a substantial post-PFO closure lifespan for these individuals Consequently it is imperative to gather more extensive long-term follow-up data among PFO closure recipients The PROLONG PFO tRanscatether Occlusion Long-term Outcomes National Group is an observational retrospective multicenter national registry including men and women undergoing transcatheter PFO closure with the aim of assessing the long-term 10 years efficacy and safety of this procedure
Detailed Description:
The PROLONG PFO Transcatheter Occlusion Long-term Outcomes National Group is an observational retrospective multicenter registry It includes 1360 subjects who underwent transcatheter patent foramen ovale PFO closure between 1999 and 2013 at 12 Italian high-volume Centers Patients will have at least 10 years of follow-up post-procedure
The primary objectives of the study are to evaluate the long-term clinical effectiveness of PFO closure by the incidence of left-sided embolic events and to evaluate safety by assessing serious device- or procedure-related adverse events Secondary objectives include the incidence of new-onset atrial arrhythmias the presence and severity of residual shunts the incidence and severity of migraine symptoms and bleeding events
The primary objectives of the study are to evaluate the long-term clinical effectiveness of PFO closure by the incidence of left-sided embolic events and to evaluate safety by assessing serious device- or procedure-related adverse events Secondary objectives include the incidence of new-onset atrial arrhythmias the presence and severity of residual shunts the incidence and severity of migraine symptoms and bleeding events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None