Effects of aortic valve calcification on outcomes after valve replacement
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: Scientific Association of Interventional Cardiology - Transcatheter Aortic Valve Replacement (SAINT-TAVR) Calcium Registry
This study is testing how the amount of calcium buildup around the aortic valve affects the long-term health of people who have had a valve replacement for severe aortic stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Eunpyeong St. Mary's Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06722066 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term effects of aortic valve annular calcification in patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. It will evaluate whether the degree of calcification prior to the procedure influences long-term clinical outcomes, including major adverse cardiovascular events and all-cause mortality, over a follow-up period of three years. Participants will have their pre-procedural imaging and clinical outcomes assessed to gather data on these relationships.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years or older who have undergone TAVR for severe aortic stenosis.
Not a fit: Patients who have not undergone TAVR or those who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that improve patient selection and management strategies for TAVR, potentially enhancing long-term outcomes.
How similar studies have performed: While there may be studies on TAVR outcomes, this specific focus on aortic annulus calcification and its long-term effects appears to be a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged 19 years or older. 2. Patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. 3. Individuals who have voluntarily provided written informed consent to participate. Exclusion Criteria: 1\. Individuals who have not provided written informed consent for this study.
Where this trial is running
Seoul
- Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Osung Kwon, MD. PhD
- Email: oscaesar@gmail.com
- Phone: +82-10-3708-5673
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.