NCT06590467 Abbott Structural Heart Device Registry
| NCT ID | NCT06590467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Heart Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2024-08-21 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2024-08-21 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Subject is willing and able to comply with the site's standard of care follow-up schedule. 3. 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 Criteria: 1\. Subject is participating in another clinical study that would affect the results of this Registry.
Contact & Investigator
Ryan Palmer
STUDY DIRECTOR
Abbott
Frequently Asked Questions
Who can join the NCT06590467 clinical trial?
This trial is open to participants of all sexes, studying Heart Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06590467 currently recruiting?
Yes, NCT06590467 is actively recruiting participants. Contact the research team at laetitia.beullens@abbott.com for enrollment information.
Where is the NCT06590467 trial being conducted?
This trial is being conducted at New Brunswick, United States, New York, United States, Philadelphia, United States, Pittsburgh, United States and 11 additional locations.
Who is sponsoring the NCT06590467 clinical trial?
NCT06590467 is sponsored by Abbott Medical Devices. The principal investigator is Ryan Palmer at Abbott. The trial plans to enroll 2,500 participants.