Better Patient Selection to Transcatheter Aortic Valve Implantation

Completed

• Conditions: Aortic Valve Stenosis; Myocardial Fibrosis; Left Ventricular Dysfunction
• Interventions: Diagnostic Test: Dobutamine stress test

• Registration Number: NCT03107923
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Study Start: 2017-04-26
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preoperative myocardial reserve yes/no	Dobutamine stress test	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.

Primary Outcome Measures

Name	Time	Method
MACE	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 Outcome Measures

Name	Time	Method
Patient quality of life (QoL)	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.
6 Minute Walking Test	1 year	Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up.
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	Number of Participants hospitalizated for heart related diseases during 12 month follow-up.

Trial Locations

Locations (2)

The Intervention Centre; 🇳🇴 Oslo, Norway

Oslo Universtity Hospital; 🇳🇴 Oslo, Norway