Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment (CRT clinic)

Region Skane

Status: Completed

Conditions: Heart Failure

Treatments: Other: Imaging guided LV lead positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01426321

CRTCLIN01

Details and patient eligibility

About

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%.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Imaging guided LV lead positioning

Active Comparator group

Treatment:

Other: Imaging guided LV lead positioning

Standard LV lead positioning

No Intervention group

Description:

The LV lead position is decided at the discretion of the treating physician. Cardiac CT images are available for viewing, but no echocardiography data regarding segmental myocardial strain are available.