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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeted Left Ventricular Lead Placement for Cardiac Resynchronization Therapy, a Randomized Trial Comparing an Active Fixation Bipolar Left Ventricular Lead and Passive Fixation Quadripolar Leads

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active fixation bipolar lead<br>Left ventricular bipolar pacemaker lead, fixated by a side helix | Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy<br>* Cardiac resynchronization therapy trial comparing types of leads.<br>|
| Placebo Comparator: Passive fixation quadripolar lead<br>Left ventricular quadripolar passive fixation pacemaker lead | Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy<br>* Cardiac resynchronization therapy trial comparing types of leads.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic response | Changes in left ventricular end-systolic volume (measured in milliliter). | 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. | 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. | 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. | Day 0 (baseline). 2, 6 and 12 months after implantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 0 (baseline). 2, 6 and 12 months after implantation | 
| Left ventricular lead impedances | Changes in left ventricular pacing impedances, measured in Ohm. | 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 | Day 0 (baseline). 6 and 12 months after implantation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization therapy