A prospective, randomized and patient-blinded trial comparing an active fixation left ventricular lead with quadripolar passive left ventricular leads. The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The patients were followed up for 12 months.
A prospective, randomized and patient-blinded trial. The objective was to compare an active fixation left ventricular lead with quadripolar passive left ventricular leads. The left ventricular segment with latest mechanical activation was identified as target segment by radial strain speckle-tracking echocardiography.The leads were compared in order to identify differences in the electrical performance, the ability to achieve a stable proximal position in a coronary vein located concordant to target segment and clinical outcome. The clinical outcomes were assessed by echocardiography, change in New York Heart Association (NYHA) functional class and Minnesota Living With Heart Failure Questionnaire (MLHFQ). The patients were followed up for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
Cardiac resynchronization therapy trial comparing types of leads.
Haukeland University Hospital, Department of Heart Disease
Bergen, Norway
Echocardiographic response
Changes in left ventricular end-systolic volume (measured in milliliter).
Time frame: Day 0 (baseline). 6 and 12 months after implantation
Ability to achieve a position in a coronary vein located concordant to target segment.
The left ventricular lead final position will be compared to the left ventricular target segment. The target segment is determined by radial strain speckle-tracking echocardiography. The lead position is classified as "concordant" or "not concordant".
Time frame: At implant (day 0)
The left ventricular lead long-axis position.
Measurement of the distance (millimeter) from the active electrode to coronary sinus. Fluoroscopic measurement in a right anterior oblique (RAO) view.
Time frame: At implant (day 0)
The left ventricular lead pacing threshold
Changes in left ventricular lead pacing capture thresholds, measured in "Volt" with 0.4ms pulse width.
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation.
Changes in NYHA functional Class
Assessment of NYHA functional Class. Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms. Class IV - Severe limitations, symptoms even while at rest.
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation
Changes in MLHFQ score
Evaluating Quality of Life. 21 questions with total scores ranging from 0 to 105. A higher score means a worse outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation
Left ventricular lead impedances
Changes in left ventricular pacing impedances, measured in "Ohm".
Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation
Changes in left ventricular ejection fraction
Changes in left ventricular ejection fraction (unit:"percent") measured by echocardiography
Time frame: Day 0 (baseline). 6 and 12 months after implantation.