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

NCT ID: NCT04632472

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-15

Study Completion Date

2018-10-31

Brief Summary

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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

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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

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Heart Failure

Keywords

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Cardiac Resynchronization therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patient blinded The echocardiographic analyses were done blinded to type of left ventricular lead.

Study Groups

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Active fixation bipolar lead

Left ventricular bipolar pacemaker lead, fixated by a side helix

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Cardiac resynchronization therapy trial comparing types of leads.

Passive fixation quadripolar lead

Left ventricular quadripolar passive fixation pacemaker lead

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

Cardiac resynchronization therapy trial comparing types of leads.

Interventions

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

Cardiac resynchronization therapy trial comparing types of leads.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Haukeland University Hospital, Department of Heart Disease

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 33426938 (View on PubMed)

Other Identifiers

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2015/1507

Identifier Type: -

Identifier Source: org_study_id