Clinical trial NCT01426321: Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment
Official title: Individually Tailored Cardiac Resynchronization Therapy - Combing Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac resynchronization therapy
Echocardiography
Cardiac computed tomography
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Crafoord Foundation
First posted: 2011-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.

New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.


Eligibility criteria: Inclusion Criteria:

* Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
* Wide QRS ≥ 120 milliseconds on standard ECG.
* LV systolic dysfunction (EF ≤ 35%).
* Written informed consent.
* Accepted for CRT-P or CRT-D treatment

Exclusion Criteria:

* Life expectancy \< 12 months.
* Recent myocardial infarction (\< 3 months).
* Significant valve disease
* Chronic atrial fibrillation
* Pregnancy
* Severely impaired renal function (estimated glomerular filtration rate (eGFR) \< 30 ml/min)
* Unable to give written informed consent.

Primary outcomes:
measure: Positive response to CRT treatment
timeFrame: 6 months
Secondary outcomes:
measure: Response to CRT (on-treatment analysis)
timeFrame: 6 months
measure: Heart failure morbidity
timeFrame: 6 months 2 years and 5 years
measure: Morbidity and mortality
timeFrame: 6 months 2 years and 5 years
measure: Mortality
timeFrame: 6 months, 2 years and 5 years
measure: Left ventricular dyssynchrony
timeFrame: 6 months
measure: Ventricular tachycardia
timeFrame: 6 months 2 years and 5 years
measure: Quality of life
timeFrame: 6 months 2 years 5 years
measure: Myocardial viability
timeFrame: Peroperative
measure: Biochemical markers of heart failure
timeFrame: 6 months
measure: Left ventricular systolic function
timeFrame: 6 months
measure: Myocardial viability
timeFrame: 6 months
measure: MRI left ventricular dyssynchrony
timeFrame: 6 months
measure: Left ventricular diastolic dimension
timeFrame: 6 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Region Skane
name: Rasmus Borgquist, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borgquist R, Carlsson M, Markstad H, Werther-Evaldsson A, Ostenfeld E, Roijer A, Bakos Z. Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging: A Randomized Controlled Study. JACC Clin Electrophysiol. 2020 Oct;6(10):1300-1309. doi: 10.1016/j.jacep.2020.05.011. Epub 2020 Aug 12.