Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry

NCT06722066 | Recruiting FDA Device

• 1 other identifier: PC24OISI0131
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  3 years follow-up

Secondary Outcomes (5)

• Hospitalization for heart failure

  3 years follow-up

• Stroke

  3 years follow-up

• Myocardial infarction

  3 years follow-up

• Permanent pacemaker insertion

  3 years follow-up

• Vascular complication

  30 days follow-up

Other Outcomes (1)

• Echo parameters

  annual follow-up until 3 years

Interventions

Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves DEVICE

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \. Individuals who have not provided written informed consent for this study.

Sponsors & Collaborators

• Eunpyeong St. Mary's Hospital: lead

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, 122-200, South Korea

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Osung Kwon, MD. PhD

CONTACT

+82-10-3708-5673; oscaesar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): December 2, 2031
• Study Completion (Estimated): October 2, 2034
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)