Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT02290028

Run by

Biotronik SE & Co. KG

People needed

2226

Starts

2014-12-16

Expected to finish

2020-01-23

Last updated by the study team

2021-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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
• Pregnant or breast-feeding at time of enrollment

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Chula Vista, California, United States
• Study site — Inglewood, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Orlando, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Bangor, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Fall River, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

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