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

Abbott Medical Devices1,078 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,078

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (64)

Ziekenhuis Oost-Limburg

Genk, Belgium

Hopital La Citadelle

Liège, Belgium

Foothills Medical Center

Calgary, Canada

Royal Alexandra Hospital

Edmonton, Canada

QE II Health Sciences

Halifax, Canada

Institut de Cardiologie du Quebec - Hopital Laval

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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)

Time frame: 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.

Time frame: Total duration of the implant procedure reported at the end of the procedure