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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active fixation bipolar lead | Active Comparator | Left ventricular bipolar pacemaker lead, fixated by a side helix |
|
| Passive fixation quadripolar lead | Placebo Comparator | Left ventricular quadripolar passive fixation pacemaker lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy | Device | Cardiac resynchronization therapy trial comparing types of leads. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital, Department of Heart Disease | Bergen | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33426938 | Derived | 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. |
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Patient blinded The echocardiographic analyses were done blinded to type of left ventricular lead.
| 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 |
| Left ventricular lead impedances | Changes in left ventricular pacing impedances, measured in "Ohm". | Day 0 (baseline). 2, 6 and 12 months after implantation |
| 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. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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