Skip to content

Echocardiography Guided Optimisation of Cardiac Resynchronization Therapy Late after Implantation

Echocardiography Guided Optimisation of Cardiac Resynchronization Therapy Late after Implantation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000805875
Acronym
CORE
Enrollment
100
Registered
2012-08-01
Start date
2007-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cardiac resynchronization therapy pacemaker devices are now an established therapy for heart failure patients. However the optimal method to set up these devices is as yet uncertain. We aim to use echocardiography to optimize these devices on a patient specific basis. We will examine no optimization vs. resting optimization vs exercise optimization in a systematic manor to determine the superior method in terms of functional and cardiac improvment.

Interventions

Heart failure patients with cardiac resynchronization therapy (CRT) devices will be investigated in a 2 stage trial investigating whether no optimization or echocardiographic CRT optimization, either at rest or on exercise, is advantageous. Optimization will occur by adjusting both the atrioventricular (AV) and ventriculo-ventricular (VV) delay of the CRT device. Stage 1 - individuals will either be randomized to no optimization or resting optimization. For this we will use the iterative method

Heart failure patients with cardiac resynchronization therapy (CRT) devices will be investigated in a 2 stage trial investigating whether no optimization or echocardiographic CRT optimization, either at rest or on exercise, is advantageous. Optimization will occur by adjusting both the atrioventricular (AV) and ventriculo-ventricular (VV) delay of the CRT device. Stage 1 - individuals will either be randomized to no optimization or resting optimization. For this we will use the iterative method for the AV delay and the Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) method for the VV delay. Stage 2 - individuals will either be randomized to resting optimization (as in stage 1) or optimization just on completion of a 6 minute walk test (exercise optimization). Resting optimization will be as in stage 1. On exercise (6 minute walk) we will only adjust the VV delay using the difference in time to systolic peak contraction between opposing LV segments at rest and then on exercise. Individuals will thus be optimized twice in total. At each visit they will undergo a resting echocardiogram, blood testing and measures of functional capacity such as treadmill walking and 6 minute walk test distance. Once at the start of stage 1 (month 1) and then at the start of stage 2 (month 7). Each optimization takes roughly 90 mins once per 6 months.

Sponsors

Cardiac Imaging Group, University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

We studied individuals who had undergone CRT implantation and were able to perform moderate exercise to level of completion of 6 minute walk test.

Exclusion criteria

Unable or unwilling to consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026