Heart Failure
Conditions
Keywords
Cardiac Resynchronization therapy
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.
Interventions
DEVICEActive fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy
Cardiac resynchronization therapy trial comparing types of leads.
Sponsors
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patient blinded The echocardiographic analyses were done blinded to type of left ventricular lead.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to achieve a position in a coronary vein located concordant to target segment. | 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. |
| The left ventricular lead long-axis position. | 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. |
| The left ventricular lead pacing threshold | 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. |
| Echocardiographic response | Day 0 (baseline). 6 and 12 months after implantation | Changes in left ventricular end-systolic volume (measured in milliliter). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NYHA functional Class | 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. |
| Changes in MLHFQ score | 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. |
| Left ventricular lead impedances | Day 0 (baseline). 2, 6 and 12 months after implantation | Changes in left ventricular pacing impedances, measured in Ohm. |
| Changes in left ventricular ejection fraction | Day 0 (baseline). 6 and 12 months after implantation. | Changes in left ventricular ejection fraction (unit:percent) measured by echocardiography |
Countries
Norway
Outcome results
None listed