Coronary Artery Disease Assessment Strategies in TAVI Patients (CAT)

May 7, 2026 updated by: Insel Gruppe AG, University Hospital Bern

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
546

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Thomas Pilgrim, MD MPH

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital Bern, Department of Cardiology
        • Contact:
          • Jonas Lanz, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion:

• 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Routine invasive coronary angiography
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.
Diagnostic test: Invasive coronary angiography
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.
Experimental: Risk-based management strategy without invasive coronary angiography
Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.
Diagnostic test: Risk-based CAD management
Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient reported health status
Time Frame: 3 months, 1, 3 and 5 years
Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health)
3 months, 1, 3 and 5 years
Patient reported health status
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)
3 months, 1, 3 and 5 years
Patient reported health status
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)
3 months, 1, 3 and 5 years
Rate of all cause death
Time Frame: 3 months, 1, 3 and 5 years
3 months, 1, 3 and 5 years
Rate of cardiovascular death
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years
Rate of disabling strokes
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years
Rate of myocardial infarction
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years
Rate of unplanned, urgent revascularization
Time Frame: 3 months, 1, 3 and 5 years
3 months, 1, 3 and 5 years
Rate of elective revascularization
Time Frame: 3 months, 1, 3 and 5 years
3 months, 1, 3 and 5 years
Rate of cardiovascular hospitalization
Time Frame: 3 months, 1, 3 and 5 years
3 months, 1, 3 and 5 years
Rate of heart failure hospitalization
Time Frame: 3 months, 1, 3 and 5 years
3 months, 1, 3 and 5 years
Rate of bleeding
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years
Rate of acute kidney injury
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years
Rate of tachyarrhythmia
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years
Rate of major vascular complications
Time Frame: 3months, 1, 3 and 5 years
(VARC-3)
3months, 1, 3 and 5 years
Rate of major cardiac structural complications
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years
Rate of permanent pacemaker implantation
Time Frame: 3 months, 1, 3 and 5 years
(VARC-3)
3 months, 1, 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Schweizerische Herzstiftung
Clinical Trials Unit Bern (CTU)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonas Lanz, MD, MSc, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAT Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

sharing via https://boris.unibe.ch platform

IPD Sharing Time Frame

after study completion

IPD Sharing Access Criteria

Data will be made available upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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