Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation (NOTION-3)

December 18, 2023 updated by: Thomas Engstrom

Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial

The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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 (Actual)

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.
454

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 Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Department of Cardiology, Skejby University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet, Copenhagen University Hospital
      • Odense, Denmark, 5000
        • Department of Cardiology, Odense University Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Turku, Finland
        • Turku University Hospital
  • Latvia
      • Riga, Latvia
        • Riga University Hospital
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska
      • Lund, Sweden
        • Lund University Hospital
      • Stockholm, Sweden
        • Karolinska

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
  3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter

Exclusion Criteria:

  1. Life expectancy < 1 year due to other severe non-cardiac disease
  2. Severe renal failure with estimated glomerular filtration rate < 20 ml/min
  3. No PCI-eligible coronary artery stenosis, but rotablation is allowed
  4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
  5. Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
  6. Only stenoses with thrombolysis in myocardial infarction grad < 3
  7. Potential pregnancy
  8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
  9. More than one chronic total occlusion (CTO)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
No Intervention: TAVI only
TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
Experimental: TAVI + FFR-guided complete revascularization
TAVI is performed according to current guidelines and the choice of transcatheter heart valve is at the operators' discretion. PCI is performed in any suitable lesion with diameter stenosis > 90% or FFR ≤ 0.80 in vessels ≥ 2.5 mm in diameter .
Procedure: PCI
FFR guided PCI

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
All-cause mortality, myocardial infarction, or urgent revascularization
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI
Until the last included patients have been followed for 1 year after the TAVI

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
All cause mortality
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing all cause mortality
Until the last included patients have been followed for 1 year after the TAVI
Myocardial infarction
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing myocardial infarction
Until the last included patients have been followed for 1 year after the TAVI
Urgent revascularization
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing urgent revascularization
Until the last included patients have been followed for 1 year after the TAVI
All cause mortality or myocardial infarction
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing all cause mortality or myocardial infarction
Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing cardiovascular mortality
Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality, myocardial infarction, or urgent PCI
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI
Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality or myocardial infarction
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing cardiovascular mortality or myocardial infarction
Until the last included patients have been followed for 1 year after the TAVI
Admission for new onset of heart failure
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing admission for new onset of heart failure
Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (PCI) myocardial infarction
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing peri-procedural (PCI) myocardial infarction
Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (TAVI) myocardial infarction
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing peri-procedural (TAVI) myocardial infarction
Until the last included patients have been followed for 1 year after the TAVI
Any revascularization
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing any revascularization
Until the last included patients have been followed for 1 year after the TAVI
Stroke or transient ischemic attack (TIA)
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing stroke or transient ischemic attack (TIA)
Until the last included patients have been followed for 1 year after the TAVI
Angina status (Seattle questionnaire), CCS and NYHA class
Time Frame: 30 days and 1 year
Number of patients experiencing CCS and NYHA class
30 days and 1 year
Bleeding
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing bleeding
Until the last included patients have been followed for 1 year after the TAVI
Quality of Life
Time Frame: 30 days and 1 year
Number of patients experiencing improvement in Quality of life
30 days and 1 year
Acute kidney injury
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing acute kidney injury
Until the last included patients have been followed for 1 year after the TAVI
Target vessel revascularization
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing target vessel revascularization
Until the last included patients have been followed for 1 year after the TAVI
Target lession revascularization
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing target lession revascularization
Until the last included patients have been followed for 1 year after the TAVI
Cost effectiveness analysis
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Cost effectiveness analysis
Until the last included patients have been followed for 1 year after the TAVI
Stent thrombosis
Time Frame: Until the last included patients have been followed for 1 year after the TAVI
Number of patients experiencing stent thrombosis
Until the last included patients have been followed for 1 year after the TAVI

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.
Thomas Engstrom

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.
Odense University Hospital
Karolinska University Hospital
Turku University Hospital
Helsinki University Central Hospital
Aarhus University Hospital
Oulu University Hospital
Rigshospitalet, Denmark
Sahlgrenska University Hospital, Sweden
Haukeland University Hospital
Aalborg University Hospital
Tampere University Hospital
Pauls Stradins Clinical University Hospital
Lund University Hospital

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.
  • Study Chair: Thomas Engstrøm, MD, DMSC, PhD, Rigshospitalet University Hospital, Denmark
  • Principal Investigator: Jacob Lønborg, MD, DMSC, PhD, Rigshospitalet University Hospital, Denmark
  • Study Chair: Lars Søndergaard, MD, DMSc, PhD, Rigshospitalet University Hospital, Denmark

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.
September 15, 2017

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.
January 15, 2024

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.
November 15, 2027

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).
February 11, 2017

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.
February 15, 2017

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.
February 23, 2017

Study Record Updates

Last Update Posted (Estimated)

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.
December 19, 2023

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.
December 18, 2023

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.
December 1, 2023

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.
  • H-16039929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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