The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm versus nominal programming. The comparison will be performed during rest, atrial pacing and sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being conducted in Europe.
Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise
Unnamed facility
Linz, Austria
Unnamed facility
Genk, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Aarhus, Denmark
Unnamed facility
Lüdenscheid, Germany
Stroke Volume at Rest
Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.
Time frame: Test day visit (within 14 days of enrollment)
Stroke Volume During Atrial Pacing.
Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.
Time frame: Test day visit (within 14 days of enrollment)
Stroke Volume During Sub-maximal Exercise.
Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.
Time frame: Test day visit (within 14 days of enrollment)
Cardiac Function With aCRT Settings at Rest
Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.
Time frame: Test day visit (within 14 days of enrollment)
Cardiac Function With Nominal Settings at Rest.
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.
Time frame: Test day visit (within 14 days of enrollment)
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Unnamed facility
Nijmegen, Netherlands
Unnamed facility
Oslo, Norway
Cardiac Function With aCRT Settings During Sub-maximal Exercise.
Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.
Time frame: Test day visit (within 14 days of enrollment)
Cardiac Function With Nominal Settings During Sub-maximal Exercise.
Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.
Time frame: Test day visit (within 14 days of enrollment)
Electrical Conduction at Rest.
Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval. The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.
Time frame: Test day visit (within 14 days of enrollment)
Electrical Conduction During Sub-maximal Exercise.
Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.
Time frame: Time Frame: Test day visit (within 14 days of enrollment)