IRB Protocol #: 1704018134
ClinicalTrials.gov Identifier: NCT02290028
Overview: The purpose of this study is to confirm the long-term safety of the BIOTRONIK Sentus QP lead used with the BIOTRONIK CRT-D device. These leads are legally marketed in the United States and not investigational products. The study involves collection and review of data at regular follow-up visits with your doctor.
This trial is funded by BIOTRONIK.
To be eligible, patients must:
- Be a candidate for CRT-D
- Be able and willing to complete all routine study visits at our site through five years of follow up
- Accept Home Monitoring® concept
Patients cannot participate if they have:
- A left ventricular lead already implanted or had prior attempt to place a left ventricular lead
- A 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
- Another life-threatening, underlying illness separate from their cardiac disorder
QP ExCELs: Sentus QP – Extended CRT Evaluation with Quadripolar Left Ventricular