Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:January 2015
End Date:May 2023
Contact:Silke Krüger, Dr.
Email:QP_ExCELs@biotronik.com
Phone:004930689051335

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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).


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:

- 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
We found this trial at
72
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Greenville, North Carolina 27834
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