Trials / Terminated
TerminatedNCT02290028
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,226 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sentus QP left ventricular lead | Implantation of quadripolar left ventricular lead in patients with CRT-D indication |
Timeline
- Start date
- 2014-12-16
- Primary completion
- 2020-01-23
- Completion
- 2020-01-23
- First posted
- 2014-11-13
- Last updated
- 2021-03-24
- Results posted
- 2021-03-24
Locations
119 sites across 11 countries: United States, Australia, Austria, Denmark, Germany, Hungary, Israel, Italy, Slovakia, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02290028. Inclusion in this directory is not an endorsement.