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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital, Department of Heart Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2016
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2015/1507

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No