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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy

• Registration Number: NCT04632472
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2016-02-15
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2020-11
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active fixation bipolar lead	Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy	Left ventricular bipolar pacemaker lead, fixated by a side helix
Passive fixation quadripolar lead	Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy	Left ventricular quadripolar passive fixation pacemaker lead

Primary Outcome Measures

Name	Time	Method
Echocardiographic response	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.	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.	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	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 Outcome Measures

Name	Time	Method
Changes in NYHA functional Class	Day 0 (baseline). 2, 6 and 12 months after implantation	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.
Left ventricular lead impedances	Day 0 (baseline). 2, 6 and 12 months after implantation	Changes in left ventricular pacing impedances, measured in "Ohm".
Changes in left ventricular ejection fraction	Day 0 (baseline). 6 and 12 months after implantation.	Changes in left ventricular ejection fraction (unit:"percent") measured by echocardiography
Changes in MLHFQ score	Day 0 (baseline). 2, 6 and 12 months after implantation	Evaluating Quality of Life. 21 questions with total scores ranging from 0 to 105. A higher score means a worse outcome.

Trial Locations

Locations (1)

Haukeland University Hospital, Department of Heart Disease; 🇳🇴 Bergen, Norway