Heart failure with dyssynchrony
Conditions
Interventions
Implantation of a CRT-D device with a quadripolar LV Lead (treatment group) or
with a traditional biventricular LV lead (control group).
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
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 informed consent form - Patients must be willing and able to comply with all study requirements
Exclusion criteria
Exclusion criteria: * Patients with a life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival from the composite endpoint of intra*operative and post*operative endpoints. Intra*operative LV lead related endpoint: * Due to phrenic nerve stimulation, lead instability or high capture threshold: o Changing to a different tributary vein of the coronary sinus following site evaluation o Using more than one LV lead during the procedure for any reason. o Using any device (eg. a stent) to actively fixate the lead * Unsuccessful implant for any reason Post*operative: Any serious adverse device effect (SADE) related to the LV lead Abandoned CRT for any reason | — |
Secondary
| Measure | Time frame |
|---|---|
| * % of CRT responders (defined as patients with a reduction in LVESV of at least 10% between baseline and the 6*month follow*up visit) * % of patients with % of Biventricular Pacing >90% at 6 months post implant * Implant procedure duration (skin to skin) * Implant fluoroscopy time * Repositioning the lead within the same vein (following unsatisfactory lead site evaluation) * Final LV lead position * Reprogramming of the LV output to | — |
Countries
Netherlands
Outcome results
None listed