NCT04632472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

November 3, 2020

Last Update Submit

November 11, 2020

Conditions

Heart Failure

Keywords

Cardiac Resynchronization therapy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Changes in NYHA functional Class

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

  • Changes in MLHFQ score

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

  • Left ventricular lead impedances

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

  • Changes in left ventricular ejection fraction

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

Study Arms (2)

Active fixation bipolar lead

ACTIVE COMPARATOR

Left ventricular bipolar pacemaker lead, fixated by a side helix

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

Passive fixation quadripolar lead

PLACEBO COMPARATOR

Left ventricular quadripolar passive fixation pacemaker lead

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

Interventions

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

Cardiac resynchronization therapy trial comparing types of leads.

Active fixation bipolar leadPassive fixation quadripolar lead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Upgrade procedures due to ventricular pacing
  • No written consensus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital, Department of Heart Disease

Bergen, 5021, Norway

Location

Related Publications (1)

  • 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.

    PMID: 33426938DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient blinded The echocardiographic analyses were done blinded to type of left ventricular lead.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 17, 2020

Study Start

February 15, 2016

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

November 17, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)