NCT04632472

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy	Cardiac resynchronization therapy trial comparing types of leads.

Timeline

• Start date: 2016-02-15
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2020-11-17
• Last updated: 2020-11-17

Locations

1 site across 1 country: Norway