Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

  • Interventional
  • Recruiting
  • NCT02290028
Eligibility Details Visit Clinicaltrials.gov

Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02290028

IRB#IRB16-0271

Lead SponsorBiotronik SE & Co. KG

Lead PhysicianHemal Nayak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting