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Trial record 1 of 1 for:    NCT02290028
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Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Biotronik SE & Co. KG
Sponsor:
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT02290028
First received: November 10, 2014
Last updated: April 7, 2017
Last verified: April 2017
  Purpose

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.

Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed during a post approval phase (US sites only).


Condition Intervention
Heart Failure
Device: Sentus QP left ventricular lead

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Sentus QP related complication-free rate through 6 months [ Time Frame: 6 months ]
    The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant.

  • Percentage of patients with acceptable pacing threshold of Sentus QP lead in permanently programmed vector at 3 months [ Time Frame: 3 months ]
    The purpose of primary endpoint 2 is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implant.

  • Sentus QP related complication-free rate through 5 years [ Time Frame: 5 years ]
    The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through 5 years post-implant (post approval phase).


Secondary Outcome Measures:
  • Sentus QP pacing threshold in permanently programmed vector at 3 months per lead model [ Time Frame: 3 months ]
    The purpose of the secondary endpoint is to evaluate the LV lead pacing threshold for the permanently programmed pacing vector at 3 months post-implantation in the two different lead types, Sentus OTW QP L and Sentus OTW QP S.

  • Sentus QP pacing threshold in novel vectors at 3 months [ Time Frame: 3 months ]
    The purpose of this secondary endpoint is to evaluate the LV lead pacing threshold for the novel pacing vector at 3 months post-implantation.

  • Sentus QP R-wave sensed amplitude at 3 months per lead model [ Time Frame: 3 months ]
    The purpose of this secondary endpoint is to evaluate the LV lead sensing amplitude at 3 months post-implantation.

  • Sentus QP pacing impedance at 3 months per lead model [ Time Frame: 3 months ]
    The purpose of this secondary endpoint is to evaluate the LV lead pacing impedance at 3 months post-implantation.

  • Sentus QP Time to first complication [ Time Frame: 6 months ]
    The purpose of this secondary is to evaluate the Sentus related complication-free rate through 6 months post-implant by the Kaplan-Meier method.

  • Sentus QP related complication-free rate through 5 years per lead model [ Time Frame: 5 years ]
    The purpose of secondary endpoint 7 is to evaluate the Sentus QP related complication-free rate through 5 years post-implant (post approval phase).

  • Individual Sentus QP adverse event rates at 5 years [ Time Frame: 5 years ]
    The purpose of secondary endpoint 8 is to evaluate the rate of individual types of adverse events related to the Sentus QP lead through 5 years post-implant (post approval phase).

  • Percentage of subjects successfully reprogrammed to resolve phrenic nerve stimulation or high pacing threshold [ Time Frame: 12 months ]
    The purpose of this secondary endpoint is to evaluate the proportion of subjects in whom PNS or high LV pacing threshold can be successfully resolved by reprogramming of the LV pacing vector


Estimated Enrollment: 1754
Study Start Date: January 2015
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sentus QP left ventricular lead
Implantation of Sentus QP left ventricular lead Pacing threshold test at PHD and 3-month follow-up
Device: Sentus QP left ventricular lead
Implantation of quadripolar left ventricular lead in patients with CRT-D indication
Other Names:
  • Sentus OTW QP L
  • Sentus OTW QP S
  • Sentus OTW QP S-xx/49

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Standard CRT-D indication according to clinical routine
  • De novo implantation or upgrade from existing ICD or pacemaker implant (with no prior attempt at LV lead placement) 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
  • 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, valve surgery, or ablation that is planned to occur within 6 months 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02290028

Contacts
Contact: Silke Krüger, Dr. 004930689051335 QP_ExCELs@biotronik.com
Contact: Crystal Miller, MS 0015034518051 QPstudyteam@biotronik.com

  Show 123 Study Locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Biotronik, Inc.
Investigators
Study Chair: Antonio Curnis, Prof. Spedali Civili - Universita di Brescia, Italy
Study Chair: Mattias Roser, Dr. Charité CBF Berlin, Germany
  More Information

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02290028     History of Changes
Other Study ID Numbers: CR016
Study First Received: November 10, 2014
Last Updated: April 7, 2017

Keywords provided by Biotronik SE & Co. KG:
CRT-D therapy
quadripolar left ventricular lead

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 26, 2017