Status:
RECRUITING
Abbott Structural Heart Device Registry
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Diseases
ASD - Atrial Septal Defect
Eligibility:
All Genders
Brief Summary
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gatherin...
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 wi...
Eligibility Criteria
Inclusion
- Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
- Subject is willing and able to comply with the site's standard of care follow-up schedule.
- Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.
Exclusion
- 1\. Subject is participating in another clinical study that would affect the results of this Registry.
Key Trial Info
Start Date :
August 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2039
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT06590467
Start Date
August 21 2024
End Date
November 1 2039
Last Update
November 17 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Odense University Hospital
Odense, Southern Denmark, Denmark, 5000
2
Tartu University Hospital
Tartu, Tartu, Estonia, 50406
3
CHRU Hopital de Pontchaillou
Rennes, Brittan, France, 35033
4
Centre Médico Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350