Transcatheter Aortic Valve ReplacementCATNCT06559332
Coronary Artery Disease Assessment Strategies in TAVI Patients
A study testing Risk-based CAD management and Invasive coronary angiography in people with Transcatheter Aortic Valve Replacement and Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
- What is being tested?
- Risk-based CAD management and Invasive coronary angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Mar 2025to 31 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s
- 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
- Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease
- Selected for treatment with transfemoral TAVI.
- Written informed consent.
Who cannot join
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
- Unprotected left main coronary stenosis >50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT
- Left ventricular ejection fraction (LVEF) < 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
- Prior left main stenting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Pilgrim, MD MPH contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Bern, Department of Cardiology
Bern, 3010
Jonas Lanz, MD, MSc
About this study
Official title: Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
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).
- Conditions
- Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
- Being tested
- Risk-based CAD management, Invasive coronary angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-based CAD managementDiagnostic test
Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.
Invasive coronary angiographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Risk-based management strategy without invasive coronary angiography | Experimental | Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended. Receives: Diagnostic Test: Risk-based CAD management |
| Routine invasive coronary angiography | Other | Routine invasive coronary angiography prior to TAVI. Percutaneous coronary intervention (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. Receives: Diagnostic Test: Invasive coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization
Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)
Measured: 3 years
Secondary outcomes (17)
Patient reported health status
Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health)
Measured: 3 months, 1, 3 and 5 years
Patient reported health status
Kansas City Cardiomyopathy Questionnaire-12 (score from 0 to 100, with higher values indicating better health)
Measured: 3 months, 1, 3 and 5 years
Patient reported health status
EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health)
Measured: 3 months, 1, 3 and 5 years
Rate of all cause death
Measured: 3 months, 1, 3 and 5 years
Rate of cardiovascular death
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Rate of disabling strokes
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Rate of myocardial infarction
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Rate of unplanned, urgent revascularization
Measured: 3 months, 1, 3 and 5 years
Rate of elective revascularization
Measured: 3 months, 1, 3 and 5 years
Rate of cardiovascular hospitalization
Measured: 3 months, 1, 3 and 5 years
Rate of heart failure hospitalization
Measured: 3 months, 1, 3 and 5 years
Rate of bleeding
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Rate of acute kidney injury
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Rate of tachyarrhythmia
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Rate of major vascular complications
(VARC-3)
Measured: 3months, 1, 3 and 5 years
Rate of major cardiac structural complications
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Rate of permanent pacemaker implantation
(VARC-3)
Measured: 3 months, 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start11 Mar 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Unit Bern (CTU), Schweizerische Herzstiftung
- Responsible party
- Sponsor
- Investigators
- Jonas Lanz, MD, MSc, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559332
- Sponsor's protocol ID
- CAT Trial
- Acronym
- CAT
- Status last verified
- May 2026
- First submitted
- 14 Aug 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing via https://boris.unibe.ch platform
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT06559332
- Acronym / sponsor ID
- CAT / CAT Trial
- Conditions
- Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Clinical Trials Unit Bern (CTU), Schweizerische Herzstiftung
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk-based management strategy without invasive coronary angiography | Experimental | Diagnostic Test: Risk-based CAD managementPatients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended. |
| Routine invasive coronary angiography | Other | Diagnostic Test: Invasive coronary angiographyRoutine invasive coronary angiography prior to TAVI. Percutaneous coronary intervention (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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s
- 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
Key exclusion criteria (7 listed)
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
- Unprotected left main coronary stenosis >50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT
- Left ventricular ejection fraction (LVEF) < 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-based CAD managementPatients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended. | Diagnostic test | Risk-based management strategy without invasive coronary angiography |
| Invasive coronary angiographyRoutine 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. | Diagnostic test | Routine invasive coronary angiography |
Primary outcome
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization
Time frame: 3 years
Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)
17 secondary outcomes
Patient reported health status
Time frame: 3 months, 1, 3 and 5 years
Patient reported health status
Time frame: 3 months, 1, 3 and 5 years
Patient reported health status
Time frame: 3 months, 1, 3 and 5 years
Rate of all cause death
Time frame: 3 months, 1, 3 and 5 years
Rate of cardiovascular death
Time frame: 3 months, 1, 3 and 5 years
Rate of disabling strokes
Time frame: 3 months, 1, 3 and 5 years
Rate of myocardial infarction
Time frame: 3 months, 1, 3 and 5 years
Rate of unplanned, urgent revascularization
Time frame: 3 months, 1, 3 and 5 years
Rate of elective revascularization
Time frame: 3 months, 1, 3 and 5 years
Rate of cardiovascular hospitalization
Time frame: 3 months, 1, 3 and 5 years
Rate of heart failure hospitalization
Time frame: 3 months, 1, 3 and 5 years
Rate of bleeding
Time frame: 3 months, 1, 3 and 5 years
Rate of acute kidney injury
Time frame: 3 months, 1, 3 and 5 years
Rate of tachyarrhythmia
Time frame: 3 months, 1, 3 and 5 years
Rate of major vascular complications
Time frame: 3months, 1, 3 and 5 years
Rate of major cardiac structural complications
Time frame: 3 months, 1, 3 and 5 years
Rate of permanent pacemaker implantation
Time frame: 3 months, 1, 3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. sharing via https://boris.unibe.ch platform
Related trials for Transcatheter Aortic Valve Replacement
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Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Pilgrim, MD MPH contact
Jonas Lanz, MD, MSc principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-based CAD management and Invasive coronary angiography in people with Transcatheter Aortic Valve Replacement and Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Lanz, MD MSc (+41 31 632 21 11, jonas.lanz@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.