Registry for evaluating TAVI procedures using CTA instead of ICA
Pre-procedural Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) - Comparision of Pre-TAVI CTA vs. Pre-TAVI ICA
This study is testing if using a non-invasive imaging method called CTA instead of a more invasive procedure can safely help older patients prepare for heart valve surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Institut für Pharmakologie und Präventive Medizin Research network |
| Drugs / interventions | radiation |
| Locations | 6 sites (Innsbruck, Tirol and 5 other locations) |
| Trial ID | NCT05750173 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of using computed tomography angiography (CTA) as a substitute for invasive coronary angiography (ICA) in patients aged 75 and older undergoing transcatheter aortic valve implantation (TAVI). The study will compare outcomes between patients receiving only CTA and those undergoing both CTA and ICA, focusing on streamlining the pre-procedural assessment while ensuring patient safety. By evaluating the effectiveness of CTA in this population, the study seeks to reduce procedural risks and costs associated with ICA. Patients will be followed up at 30 days and 3 months post-procedure to gather comprehensive data on outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 75 and older with severe aortic stenosis who are scheduled for TAVI and can undergo CTA.
Not a fit: Patients with significant coronary artery disease already diagnosed or those with a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify the pre-procedural assessment for elderly patients undergoing TAVI, reducing risks and costs associated with invasive procedures.
How similar studies have performed: While the use of CTA in this context is gaining interest, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Investigational CTA-only Cohort * Consecutive adult patients ≥ 75 years * Consecutive patients with severe AS (symptomatic or asymptomatic) with a guideline-based indication to undergo implantation of a transcatheter heart valve of the SAPIEN family * Ability to undergo CTA * Patient is scheduled to undergo a 30 Day and 3 Months follow-up CTA+ICA control Cohort * Consecutive adult patients ≥ 75 years * Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis * Ability to undergo CTA and ICA Exclusion Criteria: investigational CTA-only Cohort * Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% * Any prior coronary revascularization / prior aortic valve replacement * Life expectancy below 12 months * Lack of informed consent / data protection statement CTA+ICA control Cohort * Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline * Any prior coronary revascularization / prior aortic valve replacement * Life expectancy below 12 months * Lack of informed consent / data protection statement
Where this trial is running
Innsbruck, Tirol and 5 other locations
- Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie — Innsbruck, Tirol, Austria (Recruiting)
- University Clinic St. Pölten — St. Pölten, Austria (Recruiting)
- Medical University of Vienna — Vienna, Austria (Not_yet_recruiting)
- Klinik Floridsdorf — Wien, Austria (Recruiting)
- University Hospital Bochum / HDZ NRW — Bad Oeynhausen, Nrw, Germany (Recruiting)
- University Hospital of the Bergmannsheil gGmbH — Bochum, Nrw, Germany (Recruiting)
Study contacts
- Principal investigator: Julia Mascherbauer, Prof. Dr. — Clinical Department for Internal Medicine 3, University Hospital St. Pölten, Austria
- Study coordinator: Marie Zielinski
- Email: marie.zielinski@ippmed.de
- Phone: 0049 44718503326
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.