Targeted Left Ventricular Lead Placement, Comparison of Active Fixation Bipolar and Passive Quadripolar Pacemaker Leads

Haukeland University Hospital

Status: Completed

Conditions: Heart Failure

Treatments: Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04632472

2015/1507

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Left Ventricular Ejection Fraction (LVEF) ≤ 35 %
• NYHA 2-4
• Electrocardiogram : left bundle branch block (LBBB) and QRS duration >120 ms or non-LBBB and QRS duration ≥150 ms
• Optimal medical treatment.

Exclusion criteria

• Upgrade procedures due to ventricular pacing
• No written consensus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups, including a placebo group

Active fixation bipolar lead

Active Comparator group

Description:

Left ventricular bipolar pacemaker lead, fixated by a side helix

Treatment:

Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy

Passive fixation quadripolar lead

Placebo Comparator group

Description:

Left ventricular quadripolar passive fixation pacemaker lead

Treatment:

Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy