More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges

Study Overview
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Brief Summary
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This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.

Official Title
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More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges

Conditions
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Postoperative Cardiac Complication, Heart Failure, Left Ventricular Cardiac Dysfunction, Inappropriate Phrenic Nerve Stimulation, Perioperative/Postoperative Complications

Intervention / Treatment
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* Procedure: BiP Group
* Device: Quad Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines Patients age is 18 years or greater Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form Patients must be willing and able to comply with all study requirements Exclusion Criteria: Patients with a life expectancy <12 months. Patients who are or may potentially be pregnant. Patient has suffered any of the following in the 4 weeks prior to enrolment: Myocardial Infarction (MI) Coronary Artery Bypass Graft (CABG) Unstable Angina Pectoris Patient has primary valvular disease which has not been corrected

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quad Group<br>Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet | Device: Quad Group<br>* Implantation of quadripolar Left ventricular (LV) lead Quartet<br>|
| Active Comparator: BiP Group<br>Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads) | Procedure: BiP Group<br>* Implantation of standard Left Ventricular (LV) lead<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead Performance | Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability. Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cardiac Resynchronization Therapy Responders | Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV) | Baseline and 6 months | 
| Implant Duration | This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group. | Total duration of the implant procedure reported at the end of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization therapy,, Heart Failure,, Left Ventricular Lead,, Quadripolar Left ventricular Lead,, Phrenic Nerve Stimulation,, Intra and post operative related complications