Assessing Aortic Stenosis Severity in Patients Undergoing TAVI
AnaTomic Stenosis Severity Derived From Computed Tomography as a Prognostic Marker in Patients With Low-flow Low-gradient Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
This study looks at how the hardness of the aortic valve affects recovery in patients with a specific type of heart condition after they have a new valve put in.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 11 sites (Montréal and 10 other locations) |
| Trial ID | NCT04914481 on ClinicalTrials.gov |
What this trial studies
The ATLAS TAVI Registry is a multicenter observational study that evaluates patients with low-flow, low-gradient aortic stenosis who have undergone Transcatheter Aortic Valve Implantation (TAVI). It focuses on the relationship between aortic valve calcification density and patient outcomes post-TAVI. By analyzing non-contrast MSCT data, the study aims to determine how the severity of aortic valve calcification impacts prognosis in these patients. This research could provide insights into optimizing treatment strategies for those with low-flow, low-gradient aortic stenosis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with low-flow, low-gradient aortic stenosis who have available non-contrast MSCT data on aortic valve calcification.
Not a fit: Patients with low-flow, low-gradient aortic stenosis who do not have non-contrast MSCT data on aortic valve calcification will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are likely to benefit most from TAVI, potentially improving outcomes for those with aortic stenosis.
How similar studies have performed: Other studies have indicated that aortic valve calcification is a significant prognostic marker, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥18 years * patient gave written informed consent for data acquisition and transfer * for LFLG AS: -- available non-contrast MSCT data on aortic valve calcification (AVC, Agatston Units) Exclusion Criteria: - LFLG AS without non-contrast MSCT data on AVC
Where this trial is running
Montréal and 10 other locations
- Montreal Heart Institute — Montréal, Canada (Recruiting)
- Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval — Québec, Canada (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- CHU de Lille — Lille, France (Recruiting)
- Hôpital Bichat - Claude-Bernard — Paris, France (Recruiting)
- Kerckhoff-Klinik — Bad Nauheim, Germany (Recruiting)
- University Heart and Vascular Center Hamburg — Hamburg, Germany (Recruiting)
- Heart Center Leipzig — Leipzig, Germany (Recruiting)
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Erasmus University Medical Centre — Rotterdam, Netherlands (Recruiting)
- University of Edinburgh — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Marie-Annick Clavel, PhD — Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada
- Study coordinator: Niklas Schofer, MD
- Email: n.schofer@uke.de
- Phone: +49-40-7410-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.