Health Condition 1: null- Heart failure
Conditions
Interventions
Intervention1: Quartet Lead: The intervention group will use the commercially available CE marked St. Jude Medical Quartet
left ventricular lead. The Quartet lead is a quadripolar over the wire design
Sponsors
SJM International Inc
St Jude Medical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients are indicated for 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 inform consent form. Patients must be willing and able to comply with all study requirements.
Exclusion criteria
Exclusion criteria: Patients with a life expectancy less than 12 months. Patients who are or may potentially be pregnant. Patient has suffered any of the following in the 4 weeks prior to enrolment. o MI o CABG o Unstable Angina Pectoris Patient has primary valvular disease which has not been corrected
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to demonstrate that using the Quartet® quadripolar left ventricular lead results in easier LV implantation procedures and less chronic lead related complications compared with existing left ventricular bipolar leads.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are to demonstrate that implanting a quadripolar lead may reduce the implant procedure duration and fluoroscopy time. The investigation will also evaluate the effects on clinical outcomes associated with using quadripolar leads instead of bipolar leads.Timepoint: Baseline and 6 months | — |
Countries
Belgium, France, Germany, India, Portugal
Contacts
Public ContactSumit Anand
St . Jude Medical India Pvt Ltd.
Outcome results
None listed