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NCT Number: NCT04632472

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Department of Heart Disease

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy

Device

Cardiac resynchronization therapy trial comparing types of leads.

Primary outcomes

  1. Echocardiographic response

    Time frame: Day 0 (baseline). 6 and 12 months after implantation

    Changes in left ventricular end-systolic volume (measured in milliliter).

  2. 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".

  3. 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.

  4. 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

  1. Changes in NYHA functional Class

    Time frame: 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.

  2. Changes in MLHFQ score

    Time frame: 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.

  3. Left ventricular lead impedances

    Time frame: Day 0 (baseline). 2, 6 and 12 months after implantation

    Changes in left ventricular pacing impedances, measured in "Ohm".

  4. Changes in left ventricular ejection fraction

    Time frame: Day 0 (baseline). 6 and 12 months after implantation.

    Changes in left ventricular ejection fraction (unit:"percent") measured by echocardiography

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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