Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590467
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Abbott Structural Heart Device Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Abbott Structural Heart Device Registry
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SH-Registry
Brief Summary:
The Abbott Structural Heart SH Registry is being conducted to confirm the safety and performance of Abbotts SH devices in a post-market real-world setting The Registry primarily involves gathering data from routine hospital practices and standard-of-care SOC procedures administered to patients All devices used in these procedures must be commercially available to the participating site A list of specific devices covered by the Registry are available upon request from the Sponsor Data generated by the Registry will be used to meet regulatory requirements such as the European Union Medical Device Regulations 2017745 that require active post-market clinical follow-up PMCF for all commercially available devices
Detailed Description:
The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures Patients will be screened for eligibility and willingness to participate prior to the procedure or if enrolled retrospectively within the following timeframes
Amplatzer portion within 7 days post-procedure
Cardiac Surgery portion within 6 months post-procedure
All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry The Registry anticipates that approximately 500 subjects per year will be enrolled The projected enrollment period is at least 5 years
The Registry will be conducted at approximately 25 sites worldwide Additional sites may be approached for participation in the Registry as needed
Follow-up visits should align with the sites routine SOC visits for the associated procedure Data collection will occur post-screening and consent and at post-procedure SOC follow-up visits Where applicable follow-up visits may occur over the telephone virtually or in-office following SOC practice
The follow-up duration will depend on the Abbott devices used during the procedure Certain devices will utilize data collection at discharge or 7 days post procedure whichever comes first short-term 1 - 3 months as applicable a mid-term 6 months and long-term follow-up 12 months visits to support clinical safety and performance data requirements Alternatively some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices lifetime
A surgical valve-specific Line Extension Sub-Study is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes Epic Max 27mm and the Epic Plus Supra 29mm
Amplatzer portion within 7 days post-procedure
Cardiac Surgery portion within 6 months post-procedure
All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry The Registry anticipates that approximately 500 subjects per year will be enrolled The projected enrollment period is at least 5 years
The Registry will be conducted at approximately 25 sites worldwide Additional sites may be approached for participation in the Registry as needed
Follow-up visits should align with the sites routine SOC visits for the associated procedure Data collection will occur post-screening and consent and at post-procedure SOC follow-up visits Where applicable follow-up visits may occur over the telephone virtually or in-office following SOC practice
The follow-up duration will depend on the Abbott devices used during the procedure Certain devices will utilize data collection at discharge or 7 days post procedure whichever comes first short-term 1 - 3 months as applicable a mid-term 6 months and long-term follow-up 12 months visits to support clinical safety and performance data requirements Alternatively some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices lifetime
A surgical valve-specific Line Extension Sub-Study is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes Epic Max 27mm and the Epic Plus Supra 29mm
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