Better Patient Selection to Transcatheter Aortic Valve Implantation

NCT03107923 | Completed DMC

• 1 other identifier: 535444
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Valve Stenosis; Left Ventricular Dysfunction; Myocardial Fibrosis

Keywords

Myocardial fibrosis; Aortic Valve Stenosis; TAVI; Outcome

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (3)

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

  1 year

• Patient quality of life (QoL)

  1 year

• 6 Minute Walking Test

  1 year

Study Arms (1)

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

Interventions

Dobutamine stress test DIAGNOSTIC_TEST

Test of myocardial reserve

Preoperative myocardial reserve yes/no

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for transfemoral aortic valve implantation at Oslo University Hospital-Rikshospitalet

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

Oslo Universtity Hospital

Oslo, 0424, Norway

Location

The Intervention Centre

Oslo, 0424, Norway

Location

Related Publications (3)

• 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.

  PMID: 25062952 BACKGROUND

• 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.

  PMID: 27241050 BACKGROUND

• Saevik M, Andersen MH, Beitnes JO, Aaberge L, Halvorsen PS. Health Related Quality of Life (HRQoL) after transcatheter aortic valve implantation in aortic stenosis patients: exploring a novel threshold for clinically significant improvement after 12 months. J Patient Rep Outcomes. 2025 May 26;9(1):58. doi: 10.1186/s41687-025-00894-1.

  PMID: 40418351 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Routine blood tests on admittance and after one year. These include markers of heart failure as S-proBNP/troponin and kindey failure as S-kreatinin/S-Cystatin C, electrolytes, Hgb

MeSH Terms

Conditions

Aortic Valve Stenosis; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Ventricular Dysfunction

Study Officials

• Erik Fosse, Professor

  The Intervention Centre, Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and research group leader

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: April 26, 2017
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)