Clinical trial NCT04632472: Targeted Left Ventricular Lead Placement, Comparison of Active Fixation Bipolar and Passive Quadripolar Pacemaker Leads
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac Resynchronization therapy
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Echocardiographic response
timeFrame: Day 0 (baseline). 6 and 12 months after implantation
measure: Ability to achieve a position in a coronary vein located concordant to target segment.
timeFrame: At implant (day 0)
measure: The left ventricular lead long-axis position.
timeFrame: At implant (day 0)
measure: The left ventricular lead pacing threshold
timeFrame: Day 0 (baseline). 2, 6 and 12 months after implantation.
Secondary outcomes:
measure: Changes in NYHA functional Class
timeFrame: Day 0 (baseline). 2, 6 and 12 months after implantation
measure: Changes in MLHFQ score
timeFrame: Day 0 (baseline). 2, 6 and 12 months after implantation
measure: Left ventricular lead impedances
timeFrame: Day 0 (baseline). 2, 6 and 12 months after implantation
measure: Changes in left ventricular ejection fraction
timeFrame: Day 0 (baseline). 6 and 12 months after implantation.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Department of Heart Disease
Study officials:
References:
citation: Keilegavlen H, Schuster P, Hovstad T, Faerestrand S. Clinical outcome of cardiac resynchronization therapy in patients randomized to an active fixation bipolar left ventricular lead versus a passive quadripolar lead. Scand Cardiovasc J. 2021 Jun;55(3):153-159. doi: 10.1080/14017431.2020.1869299. Epub 2021 Jan 10.