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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital, Department of Heart Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active fixation bipolar lead

Passive fixation quadripolar lead

Arm Description

Left ventricular bipolar pacemaker lead, fixated by a side helix

Left ventricular quadripolar passive fixation pacemaker lead

Outcomes

Primary Outcome Measures

Echocardiographic response
Changes in left ventricular end-systolic volume (measured in milliliter).
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".
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.
The left ventricular lead pacing threshold
Changes in left ventricular lead pacing capture thresholds, measured in "Volt" with 0.4ms pulse width.

Secondary Outcome Measures

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.
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.
Left ventricular lead impedances
Changes in left ventricular pacing impedances, measured in "Ohm".
Changes in left ventricular ejection fraction
Changes in left ventricular ejection fraction (unit:"percent") measured by echocardiography

Full Information

First Posted
November 3, 2020
Last Updated
November 11, 2020
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04632472
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Resynchronization therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patient blinded The echocardiographic analyses were done blinded to type of left ventricular lead.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active fixation bipolar lead
Arm Type
Active Comparator
Arm Description
Left ventricular bipolar pacemaker lead, fixated by a side helix
Arm Title
Passive fixation quadripolar lead
Arm Type
Placebo Comparator
Arm Description
Left ventricular quadripolar passive fixation pacemaker lead
Intervention Type
Device
Intervention Name(s)
Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
Intervention Description
Cardiac resynchronization therapy trial comparing types of leads.
Primary Outcome Measure Information:
Title
Echocardiographic response
Description
Changes in left ventricular end-systolic volume (measured in milliliter).
Time Frame
Day 0 (baseline). 6 and 12 months after implantation
Title
Ability to achieve a position in a coronary vein located concordant to target segment.
Description
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".
Time Frame
At implant (day 0)
Title
The left ventricular lead long-axis position.
Description
Measurement of the distance (millimeter) from the active electrode to coronary sinus. Fluoroscopic measurement in a right anterior oblique (RAO) view.
Time Frame
At implant (day 0)
Title
The left ventricular lead pacing threshold
Description
Changes in left ventricular lead pacing capture thresholds, measured in "Volt" with 0.4ms pulse width.
Time Frame
Day 0 (baseline). 2, 6 and 12 months after implantation.
Secondary Outcome Measure Information:
Title
Changes in NYHA functional Class
Description
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.
Time Frame
Day 0 (baseline). 2, 6 and 12 months after implantation
Title
Changes in MLHFQ score
Description
Evaluating Quality of Life. 21 questions with total scores ranging from 0 to 105. A higher score means a worse outcome.
Time Frame
Day 0 (baseline). 2, 6 and 12 months after implantation
Title
Left ventricular lead impedances
Description
Changes in left ventricular pacing impedances, measured in "Ohm".
Time Frame
Day 0 (baseline). 2, 6 and 12 months after implantation
Title
Changes in left ventricular ejection fraction
Description
Changes in left ventricular ejection fraction (unit:"percent") measured by echocardiography
Time Frame
Day 0 (baseline). 6 and 12 months after implantation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Haukeland University Hospital, Department of Heart Disease
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33426938
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.
Results Reference
derived

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

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