Better Patient Selection to Transcatheter Aortic Valve Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03107923
Recruitment Status : Not yet recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Per Steinar Halvorsen, Oslo University Hospital

Brief Summary:
This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Left Ventricular Dysfunction Myocardial Fibrosis Diagnostic Test: Dobutamine stress test

Detailed Description:
In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Better Patient Selection to Transcatheter Aortic Valve Implantation
Estimated Study Start Date : April 26, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Group/Cohort Intervention/treatment
Preoperative myocardial reserve yes/no
Patients with extensive myocardial fibrosis typically presents with limited myocardial contractile reserve that can be assessed by a dobutamine stress test. The patients will be allocated to a responder and non-responder group according to the results from this test.
Diagnostic Test: Dobutamine stress test
Test of myocardial reserve

Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
    Mortality at 12 months follow-up after TAVI

Secondary Outcome Measures :
  1. Cardiac morbidity [ Time Frame: 1 year ]
    Hospitalization for heart related diseases.

Other Outcome Measures:
  1. Quality of life [ Time Frame: 1 year ]
    SF 36

  2. Left ventricular function [ Time Frame: 1 year ]
    Dimensions, and systolic and diastolic function

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for transfemoral aortic valve implantation at Oslo University Hospital-Rikshospitalet

Inclusion Criteria:

  • Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation.

Exclusion Criteria:

  • Aortic valve endocarditis
  • aortic annulus >31mm
  • preoperative pacemaker
  • severe aortic insufficiency (>grad 3)
  • rapid atrial fibrillation
  • unprotected left main coronary stenosis not suitable for percutaneous intervention.
  • unstable angina
  • life expectancy less than 12 months
  • mental disorder including dementia and condition which interferes with protocol compliance.
  • renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI.
  • Patients with metal not suitable for MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03107923

Contact: Erik Fosse, Professor +4723070100

The Intervention Centre, Oslo Universtity Hospital Not yet recruiting
Oslo, Norway, 0424
Contact: Per Steinar Halvorsen, MD, PhD    +4746431499   
Contact: Jan Otto Beitnes, MD, PhD    +4792022152   
Sponsors and Collaborators
Oslo University Hospital

Responsible Party: Per Steinar Halvorsen, Consultant and research group leader, Oslo University Hospital Identifier: NCT03107923     History of Changes
Other Study ID Numbers: 535444
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Per Steinar Halvorsen, Oslo University Hospital:
Myocardial fibrosis
Aortic Valve Stenosis

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Aortic Valve Stenosis
Pathologic Processes
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents