Replace Pre-TAVI ICA by Performing CTA

Sponsor

Institut für Pharmakologie und Präventive Medizin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05750173

Collaborator

Edwards Lifesciences (Industry)

150

Enrollment

21.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Transcatheter Aortic Valve Implantation (TAVI)	Other: Streamlining of the pre-procedural patient pathway

Detailed Description

Patients undergoing TAVI require routine pre-procedural assessment of CAD (coronary artery disease).

ICA (invasive coronary angiography) is the gold standard in patients with high pre-test probability. It is associated, however, with procedural risk, radiation and cost.

CTA (computed tomography angiography) currently has limited use for the evaluation of CAD in pts with severe symptomatic AS (aortic stenosis) - medications required such as beta blockers and nitroglycerine, are frequently not well tolerated by pts.

But as TAVI is increasingly being performed in patients with modest pre-test probabilities for obstructive CAD or a lack of implications thereof (pts. ≥75 yrs), the use of CTA may become more appealing.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Replace Pre-TAVI Invasive Coronary Angiography (ICA) by Performing Computed Tomography Angiography (CTA)

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Prospective cohort 100 consecutive patients that are not already diagnosed with severe (≥50%) proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM).	Other: Streamlining of the pre-procedural patient pathway Pre-TAVI ICA is associated with procedural risk, radiation, costs and requires hospitalization (2d). Show that CTA is a viable alternative to rule out ≥50% left main coronary artery (LM) / prox. left anterior descending artery (LAD) stenosis. An implementation of a standardized patient pathway which is reproducible, will help to streamline the pre-procedural workup of patients without compromising patient safety.
Retrospective cohort 50 consecutive patients from the participating centers that already underwent CTA and ICA prior to TAVI will serve as a "historical control" group.

Arm

Intervention/Treatment

Prospective cohort

100 consecutive patients that are not already diagnosed with severe (≥50%) proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM).

Other: Streamlining of the pre-procedural patient pathway

Pre-TAVI ICA is associated with procedural risk, radiation, costs and requires hospitalization (2d). Show that CTA is a viable alternative to rule out ≥50% left main coronary artery (LM) / prox. left anterior descending artery (LAD) stenosis. An implementation of a standardized patient pathway which is reproducible, will help to streamline the pre-procedural workup of patients without compromising patient safety.

Retrospective cohort

50 consecutive patients from the participating centers that already underwent CTA and ICA prior to TAVI will serve as a "historical control" group.

Outcome Measures

Primary Outcome Measures

Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI [30 days]
CAD specific combined "endpoint" at 30 days All-cause death Non-fatal myocardial infarction Ischemia-driven revascularization Rehospitalization (valve- or procedure-related including heart failure) Life-threatening/disabling or major bleeding Number and percentage of subjects with above specified outcomes at 30 days
Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI [3 months]
CAD specific combined "endpoint" at 3 months All-cause death Non-fatal myocardial infarction Ischemia-driven revascularization Rehospitalization (valve- or procedure-related including heart failure) Life-threatening/disabling or major bleeding Number and percentage of subjects with above specified outcomes at 3 months.
Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria [30 days]
VARC-3 defined device success at 30 days: Technical success Freedom from mortality Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) Number and percentage of subjects with device success at 30 days as per VARC-3 definition.
Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria [30 days]
VARC-3 defined early safety at 30 days: Freedom from all-cause mortality Freedom from all Stroke Freedom from all VARC type 2-4 bleeding Freedom from all major vascular, access-related, or cardiac structural complication Freedom from all acute kidney injury stage III/IV Freedom from all moderate/severe aortic regurgitation Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities Freedom from all surgery/intervention related to the device Number and percentage of subjects free from VARC3-defined safety issues at 30 days as per VARC-3 definition.

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Prospective 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

Retrospective Cohort

Consecutive adult patients ≥ 75 years
Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis
Patients underwent both CTA and ICA before the procedure
Patient underwent a 30 Day and 3 Months follow-up

Exclusion Criteria:

Prospective Cohort

Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50%
Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Prior pacemaker implantation (PPI)
Valve in valve intervention (ViV)
Life expectancy below 12 months
Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)

Retrospective Cohort

Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline
Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Prior pacemaker implantation (PPI)
Valve in valve intervention (ViV)
Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)