University Hospital Bern, Department of Cardiology
Bern, 3010, Switzerland
Location status: Recruiting
Location contact
Jonas Lanz, MD, MSc
CONTACT
NCT Number: NCT06559332
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status.
As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear.
The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Not applicable
Bern, 3010, Switzerland
Location status: Recruiting
Jonas Lanz, MD, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
OR
if mean gradient <40 mmHg and peak velocity (Vmax) <4 m/s and stroke volume indexed to body surface area (SVi) ≤ 35 mL/m2 and LVEF ≥50% then if CT-derived aortic valve calcium score >2000 Agatston units in men, >1200 in women
OR
if mean gradient <40 mmHg and Vmax <4 m/s and SVi ≤ 35 mL/m2 and LVEF <50% then if CT-derived aortic valve calcification >2000 Agatston units in men, >1200 in women OR if low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke volume) and AVA ≤1cm2
Exclusion criteria
Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.
Routine invasive coronary angiography prior to TAVI. PCI recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.
Time frame: 3 years
Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)
Time frame: 3 months, 1, 3 and 5 years
Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health)
Time frame: 3 months, 1, 3 and 5 years
Kansas City Cardiomyopathy Questionnaire-12 (score from 0 to 100, with higher values indicating better health)
Time frame: 3 months, 1, 3 and 5 years
EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health)
Time frame: 3 months, 1, 3 and 5 years
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Time frame: 3 months, 1, 3 and 5 years
Time frame: 3 months, 1, 3 and 5 years
Time frame: 3 months, 1, 3 and 5 years
Time frame: 3 months, 1, 3 and 5 years
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Time frame: 3months, 1, 3 and 5 years
(VARC-3)
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Time frame: 3 months, 1, 3 and 5 years
(VARC-3)
Contact information is provided by the study sponsor or research team.
Insel Gruppe AG, University Hospital Bern
Other
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Acronym: CAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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