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Completed

NCT Number: NCT03107923

Better Patient Selection to Transcatheter Aortic Valve Implantation

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Left Ventricular Dysfunction Myocardial Fibrosis Ventricular Dysfunction Ventricular Dysfunction, Left Ventricular Outflow Obstruction

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo Universtity Hospital, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dobutamine stress test

Diagnostic Test

Test of myocardial reserve

Primary outcomes

  1. MACE

    Time frame: 1 year

    MACE at 12 months follow-up after TAVI, MACE definition: rehospitalization for heart failure or other valve related complications, nonfatal myocardial infarction, nonfatal stroke, or (cardiovascular) death

Secondary outcomes

  1. NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome

    Time frame: 1 year

    Number of Participants hospitalizated for heart related diseases during 12 month follow-up.

  2. Patient quality of life (QoL)

    Time frame: 1 year

    Quality of life record (SF 36), Physical function (age adjusted normal value 71.6 (SD 26.9)) and Physical role (age adjusted normal value 57.0 (SD 43.8)) , the patients were divided into groups using the predefined minimal change of 15 and 18,75 points, respectively. Changes above these tresholds at 12 month follow-up indicat better QoL outcomes.

  3. 6 Minute Walking Test

    Time frame: 1 year

    Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2017
Registry last updated
Jun 29, 2023

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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