Aortic StenosisSAINT-TAVR CaNCT06722066
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry
An observational study of Aortic Stenosis, run by Eunpyeong St. Mary's Hospital at 1 site in South Korea.
Trial summary
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2024to 2 Oct 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 19 years or older who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis and have voluntarily expressed their willingness to participate through written informed consent.
Who may be able to join
- Adults aged 19 years or older.
- Patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis.
- Individuals who have voluntarily provided written informed consent to participate.
Who cannot join
- 1. Individuals who have not provided written informed consent for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, 122-200
Hye-Yeon Seo, A Master´s degree, +82-10-9151-9028, hymargie@hanmail.net
About this study
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
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:
Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?
Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacement with ballon-expandable or self-expandable valvesDevice
Device: Edwards SAPIEN 3 valve, Medtronic Evolut valve, Boston Acurate Neo valve, or Abbott Navitor Access route: transfemorak, subclavian, transapical, transcarotid, or transcaval The use of balloon dilation will be left to the discretion of the operator.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 3 years follow-up
Secondary outcomes (5)
Hospitalization for heart failure
Measured: 3 years follow-up
Stroke
Measured: 3 years follow-up
Myocardial infarction
Measured: 3 years follow-up
Permanent pacemaker insertion
Measured: 3 years follow-up
Vascular complication
Measured: 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start2 Oct 2024
- Primary completion2 Dec 2031 (estimated)
- Study completion2 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunpyeong St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osung Kwon, Eunpyeong St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722066
- Sponsor's protocol ID
- PC24OISI0131
- Acronym
- SAINT-TAVR Ca
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06722066
- Acronym / sponsor ID
- SAINT-TAVR Ca / PC24OISI0131
- Conditions
- Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Eunpyeong St. Mary's HospitalUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 2 Dec 2031 (estimated)
- Study completion
- 2 Oct 2034 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:
Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?
Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 19 years or older who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis and have voluntarily expressed their willingness to participate through written informed consent.
Key inclusion criteria (3 listed)
- Adults aged 19 years or older.
- Patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis.
- Individuals who have voluntarily provided written informed consent to participate.
Key exclusion criteria (1 listed)
- 1. Individuals who have not provided written informed consent for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter aortic valve replacement with ballon-expandable or self-expandable valvesDevice: Edwards SAPIEN 3 valve, Medtronic Evolut valve, Boston Acurate Neo valve, or Abbott Navitor Access route: transfemorak, subclavian, transapical, transcarotid, or transcaval The use of balloon dilation will be left to the discretion of the operator. | Device | – |
Primary outcome
All-cause mortality
Time frame: 3 years follow-up
5 secondary outcomes
Hospitalization for heart failure
Time frame: 3 years follow-up
Stroke
Time frame: 3 years follow-up
Myocardial infarction
Time frame: 3 years follow-up
Permanent pacemaker insertion
Time frame: 3 years follow-up
Vascular complication
Time frame: 30 days follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Yes
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Eunpyeong St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osung Kwon, MD. PhD (+82-10-3708-5673, oscaesar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.