Effects of aortic valve calcification on outcomes after valve replacement
Official title: 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
Run by Eunpyeong St. Mary's Hospital · NCT06722066 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Eunpyeong St. Mary's Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | October 2, 2024 |
| Main results expected | December 2, 2031 |
| Study ends | October 2, 2034 |
| Registry record updated | December 9, 2024 |
| Trial ID | NCT06722066 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 19 years or older who have undergone TAVR for severe aortic stenosis.
✕Probably not a fit
Patients who have not undergone TAVR or those who do not provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
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Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
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Echo-AVCS: Drawing AI-powered clues from heart scans to confirm severe aortic stenosis
This study tests an AI-based echocardiography score to help confirm severe aortic stenosis in adults who are also getting CT calcium scoring.
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TAVI without on-site heart surgery: can selected centers do it safely?
This trial tests whether transcatheter aortic valve implantation can be done safely in certain hospitals that don’t have on-site cardiac surgery, for patients with severe aortic stenosis who are appropriately selected.
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Willem AI for early detection of aortic stenosis from a 12‑lead ECG
This project will test whether the Willem AI can detect aortic stenosis from routine 12‑lead ECGs in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.