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Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

NCT02290028 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2226

Last updated 2021-03-24

Study results available
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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

DEVICE

Sentus QP left ventricular lead

Implantation of quadripolar left ventricular lead in patients with CRT-D indication

Sponsors & Collaborators

  • Biotronik, Inc.

    collaborator INDUSTRY

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Antonio Curnis, Prof. · Spedali Civili - Universita di Brescia, Italy

  • Mattias Roser, Dr. · Charité CBF Berlin, Germany

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-16
Primary Completion
2020-01-23
Completion
2020-01-23

Countries

  • United States
  • Australia
  • Austria
  • Denmark
  • Germany
  • Hungary
  • Israel
  • Italy
  • Slovakia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02290028 on ClinicalTrials.gov