Better Patient Selection to Transcatheter Aortic Valve Implantation

Oslo University Hospital103 enrolled

Overview

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.

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

Enrollment

103

Conditions

Aortic Valve Stenosis Left Ventricular Dysfunction Myocardial Fibrosis

Interventions

Dobutamine stress testDIAGNOSTIC_TEST

Test of myocardial reserve

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (2)

Oslo Universtity Hospital

Oslo, Norway

The Intervention Centre

Oslo, Norway

Outcomes

Primary Outcomes

MACE

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

Time frame: 1 year

Secondary Outcomes

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

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

Time frame: 1 year

Patient quality of life (QoL)

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.

Time frame: 1 year

6 Minute Walking Test

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

Time frame: 1 year

Data from ClinicalTrials.gov

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