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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Haukeland University Hospital
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Echocardiographic response
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Left Ventricular Ejection Fraction (LVEF) ≤ 35 %
- •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
Outcomes
Primary Outcomes
Echocardiographic response
Time Frame: Day 0 (baseline). 6 and 12 months after implantation
Changes in left ventricular end-systolic volume (measured in milliliter).
The left ventricular lead long-axis position.
Time Frame: At implant (day 0)
Measurement of the distance (millimeter) from the active electrode to coronary sinus. Fluoroscopic measurement in a right anterior oblique (RAO) view.
Ability to achieve a position in a coronary vein located concordant to target segment.
Time Frame: At implant (day 0)
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".
The left ventricular lead pacing threshold
Time Frame: Day 0 (baseline). 2, 6 and 12 months after implantation.
Changes in left ventricular lead pacing capture thresholds, measured in "Volt" with 0.4ms pulse width.
Secondary Outcomes
- Changes in NYHA functional Class(Day 0 (baseline). 2, 6 and 12 months after implantation)
- Left ventricular lead impedances(Day 0 (baseline). 2, 6 and 12 months after implantation)
- Changes in left ventricular ejection fraction(Day 0 (baseline). 6 and 12 months after implantation.)
- Changes in MLHFQ score(Day 0 (baseline). 2, 6 and 12 months after implantation)