Pre-procedural Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) - Comparision of Pre-TAVI CTA vs. Pre-TAVI ICA

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
View:

⁃ 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

Locations
Other Locations
Austria
Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie
RECRUITING
Innsbruck
University Clinic St. Pölten
RECRUITING
Sankt Pölten
Klinik Floridsdorf
RECRUITING
Vienna
Medical University of Vienna
NOT_YET_RECRUITING
Vienna
Germany
University Hospital Bochum / HDZ NRW
RECRUITING
Bad Oeynhausen
University Hospital of the Bergmannsheil gGmbH
RECRUITING
Bochum
Contact Information
Primary
Marie Zielinski
marie.zielinski@ippmed.de
0049 44718503326
Backup
Kerstin Plate
kerstin.plate@ippmed.de
044718503331
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 150
Treatments
Investigational CTA-only cohort
100 consecutive patients that are not already diagnosed with significant (≥50%) proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) and who have not previously undergone coronary revascularisation.
CTA+ICA control cohort
At least 50 consecutive patients who have not already been diagnosed with significant (≥50%) LM / proximal LAD stenosis an who have not previously undergone conronary revascularisation and will undergo CTA. If LM / proximal LAD stenosis of ≥50% can be ruled out and ICA is also performed prior to TAVI these patients will serve as control group.
Sponsors
Collaborators: Edwards Lifesciences
Leads: Institut für Pharmakologie und Präventive Medizin

This content was sourced from clinicaltrials.gov