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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632472
• Other study ID #: 2015/1507
• Status: Completed
• Phase: N/A
• Start date: February 15, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: November 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
Cardiac resynchronization therapy trial comparing types of leads.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital, Department of Heart Disease	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic response	Changes in left ventricular end-systolic volume (measured in milliliter).	Day 0 (baseline). 6 and 12 months after implantation
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	Left ventricular lead impedances	Changes in left ventricular pacing impedances, measured in "Ohm".	Day 0 (baseline). 2, 6 and 12 months after implantation
Secondary	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.