Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)

Biotronik

Status

Terminated

Conditions

Heart Failure

Treatments

Device: Sentus QP left ventricular lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT02290028

CR016

Details and patient eligibility

About

The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.

Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed during the ongoing post approval phase (US sites only).

A protocol update was implemented on September 6, 2019 to transition the long-term follow up for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.

Enrollment

2,226 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Pregnant or breast-feeding at time of enrollment