Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotronik SE & Co. KG
With
Biotronik, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Standard CRT-D indication according to clinical routine
De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead
Patient is able to understand the nature of the clinical investigation and provide written informed consent
Patient is able and willing to complete all routine study visits at the investigational site through 5 years of follow-up
Patient accepts Home Monitoring® concept
Age ≥ 18 years
You may not be if
Chronic atrial fibrillation
Contraindication to CRT-D therapy
Currently implanted with an endocardial or epicardial left ventricular lead or had prior attempt to place a left ventricular lead
Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that is planned to occur within 6 months after implant or ablation that is planned to occur within 90 days after implant (ablations planned to occur prior to or at implant are not exclusionary)
Expected to receive a heart transplant or ventricular assist device within 6 months
Life expectancy less than 12 months
Participation in any other investigational cardiac clinical investigation during the course of the study
Presence of another life-threatening, underlying illness separate from their cardiac disorder
