Clinical trial NCT03107923: Better Patient Selection to Transcatheter Aortic Valve Implantation
Official title: Better Patient Selection to Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Left Ventricular Dysfunction
Myocardial Fibrosis
Keywords: Myocardial fibrosis
Aortic Valve Stenosis
TAVI
Outcome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for transfemoral aortic valve implantation at Oslo University Hospital-Rikshospitalet

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MACE
timeFrame: 1 year
Secondary outcomes:
measure: NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome
timeFrame: 1 year
measure: Patient quality of life (QoL)
timeFrame: 1 year
measure: 6 Minute Walking Test
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universtity Hospital
city: Oslo
country: Norway
facility: The Intervention Centre
Study officials:
affiliation: The Intervention Centre, Oslo University Hospital
name: Erik Fosse, Professor
role: STUDY_DIRECTOR
References:
citation: Bax JJ, Delgado V, Bapat V, Baumgartner H, Collet JP, Erbel R, Hamm C, Kappetein AP, Leipsic J, Leon MB, MacCarthy P, Piazza N, Pibarot P, Roberts WC, Rodes-Cabau J, Serruys PW, Thomas M, Vahanian A, Webb J, Zamorano JL, Windecker S. Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation. Eur Heart J. 2014 Oct 7;35(38):2627-38. doi: 10.1093/eurheartj/ehu256. Epub 2014 Jul 25.
citation: Eidet J, Dahle G, Bugge JF, Bendz B, Rein KA, Aaberge L, Offstad JT, Fosse E, Aakhus S, Halvorsen PS. Long-term outcomes after transcatheter aortic valve implantation: the impact of intraoperative tissue Doppler echocardiography. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):403-9. doi: 10.1093/icvts/ivw159. Epub 2016 May 30.