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Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads (QP ExCELs)

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ClinicalTrials.gov Identifier: NCT02290028
Recruitment Status : Recruiting
First Posted : November 13, 2014
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief 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).


Condition or disease Intervention/treatment Phase
Heart Failure Device: Sentus QP left ventricular lead Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1754 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Study Start Date : January 2015
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
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
  • Sentus OTW QP L-xx/49




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290028


Contacts
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Contact: Silke Krüger, Dr. 004930689051335 QP_ExCELs@biotronik.com
Contact: Karlene Cox, MS 0015034518072 QPstudyteam@biotronik.com

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Locations
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United States, Alabama
Recruiting
Fairhope, Alabama, United States
United States, Alaska
Terminated
Anchorage, Alaska, United States
United States, California
Recruiting
Chula Vista, California, United States
Recruiting
Inglewood, California, United States
Withdrawn
Mission Viejo, California, United States
Recruiting
Rancho Mirage, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Recruiting
Orlando, Florida, United States, 32803
Recruiting
Orlando, Florida, United States, 32806
Terminated
Pensacola, Florida, United States
Withdrawn
Tampa, Florida, United States, 33606
Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Recruiting
Atlanta, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
Terminated
Joliet, Illinois, United States
United States, Indiana
Recruiting
Fort Wayne, Indiana, United States
United States, Iowa
Recruiting
Iowa City, Iowa, United States
United States, Kansas
Recruiting
Kansas City, Kansas, United States
United States, Kentucky
Recruiting
Lexington, Kentucky, United States, 40503
Recruiting
Lexington, Kentucky, United States, 40536
United States, Louisiana
Recruiting
New Orleans, Louisiana, United States
United States, Maine
Recruiting
Bangor, Maine, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
Recruiting
Burlington, Massachusetts, United States
Recruiting
Fall River, Massachusetts, United States
Recruiting
Worcester, Massachusetts, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
Recruiting
Detroit, Michigan, United States
Recruiting
Ypsilanti, Michigan, United States
United States, Mississippi
Recruiting
Tupelo, Mississippi, United States
United States, Missouri
Terminated
Kansas City, Missouri, United States
Recruiting
Saint Charles, Missouri, United States
Recruiting
Saint Louis, Missouri, United States, 63110
Recruiting
Saint Louis, Missouri, United States, 63136
Recruiting
Springfield, Missouri, United States
United States, Montana
Recruiting
Kalispell, Montana, United States
United States, New Jersey
Recruiting
Browns Mills, New Jersey, United States
Terminated
Englewood, New Jersey, United States
Recruiting
Hackensack, New Jersey, United States
Recruiting
Neptune, New Jersey, United States
United States, New York
Recruiting
Bronx, New York, United States
Terminated
Brooklyn, New York, United States
Recruiting
Flushing, New York, United States
Recruiting
New York, New York, United States, 10016
Recruiting
New York, New York, United States, 10021
Recruiting
New York, New York, United States, 10025
Terminated
New York, New York, United States, 10029
Recruiting
Valhalla, New York, United States
United States, North Carolina
Recruiting
Asheville, North Carolina, United States
Recruiting
Chapel Hill, North Carolina, United States
Active, not recruiting
Greensboro, North Carolina, United States
Recruiting
Greenville, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States, 27103
Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Recruiting
Fargo, North Dakota, United States
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45219
Withdrawn
Cincinnati, Ohio, United States, 45220
Recruiting
Columbus, Ohio, United States, 43210
Recruiting
Columbus, Ohio, United States, 43214
Withdrawn
Toledo, Ohio, United States, 43608
Recruiting
Toledo, Ohio, United States, 43615
United States, Pennsylvania
Recruiting
Bryn Mawr, Pennsylvania, United States
Withdrawn
Langhorne, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
Recruiting
Wynnewood, Pennsylvania, United States
United States, Rhode Island
Terminated
Warwick, Rhode Island, United States
United States, South Carolina
Recruiting
Anderson, South Carolina, United States
Recruiting
Columbia, South Carolina, United States
Recruiting
Greenville, South Carolina, United States
United States, Tennessee
Recruiting
Chattanooga, Tennessee, United States
United States, Texas
Terminated
Amarillo, Texas, United States
Recruiting
Fort Worth, Texas, United States
Withdrawn
Galveston, Texas, United States
Terminated
San Antonio, Texas, United States
Recruiting
The Woodlands, Texas, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Vermont
Recruiting
Burlington, Vermont, United States
United States, Virginia
Active, not recruiting
Norfolk, Virginia, United States
United States, Washington
Withdrawn
Spokane, Washington, United States
United States, Wisconsin
Recruiting
Milwaukee, Wisconsin, United States
United States, Wyoming
Terminated
Cheyenne, Wyoming, United States
Australia
Flinders Medical Center Completed
Bedford Park, Australia
Lyell McEwing Hospital Completed
Elizabeth Vale, Australia
The Northern Hospital Completed
Epping, Australia
Royal Hobart Hospital Completed
Hobart, Australia
Nambour General Hospital Completed
Nambour, Australia
Austria
AKH Linz Completed
Linz, Austria
Klinikum Wels-Grieskirchen GmbH Completed
Wels, Austria
AKH Wien Completed
Wien, Austria
Denmark
Aalborg Universitetshospital Withdrawn
Aalborg, Denmark
Gentofte Hospital Completed
Hellerup, Denmark
Odense Universitets Hospital Completed
Odense, Denmark
Germany
Charité Campus Benjamin Franklin Withdrawn
Berlin, Germany
DHZ Berlin Completed
Berlin, Germany
Maria Heimsuchung Caritas Klinik Pankow Completed
Berlin, Germany
Virchow Klinikum Completed
Berlin, Germany
Immanuel Klinikum Herzzentrum Bernau Completed
Bernau, Germany
Städtisches Krankenhaus Bielefeld Mitte Completed
Bielefeld, Germany
Augusta-Kranken-Anstalt Bochum Completed
Bochum, Germany
Augusta Krankenhaus Düsseldorf Completed
Düsseldorf, Germany
Heinrich Heine University Düsseldorf Completed
Düsseldorf, Germany
Universitätsklinik Erlangen Completed
Erlangen, Germany
Elisabeth Krankenhaus Essen Completed
Essen, Germany
UHZ Freiburg Completed
Freiburg, Germany
SRH Wald-Klinikum Gera gGmbH Completed
Gera, Germany
Westpfalzklinikum Completed
Kaiserslautern, Germany
Städtisches Klinikum St. Georg Completed
Leipzig, Germany
UKSH Campus Lübeck Completed
Lübeck, Germany
Marienhospital Lünen Completed
Lünen, Germany
Elbekliniken Stade - Buxtehude Completed
Stade, Germany
Robert-Bosch Krankenhaus Withdrawn
Stuttgart, Germany
SBK Villingen Schwenningen Completed
Villingen, Germany
SHG-Kliniken Völklingen Completed
Völklingen, Germany
Universitätsklinikum Würzburg Completed
Würzburg, Germany
HBK Zwickau Completed
Zwickau, Germany
Hungary
Semmelweis University Completed
Budapest, Hungary
Israel
Barzilai Medical Center Completed
Ashkelon, Israel
Soroka Medical Center Completed
Beer Sheva, Israel
Rambam Medical Center Completed
Haifa, Israel
Hadassah Medical Center Completed
Jerusalem, Israel
Meir Medical Center Withdrawn
Kfar Saba, Israel
Italy
Spedali Civili di Brescia Completed
Brescia, Italy
Azienda Ospedaliero Sant`Anna Como Completed
Como, Italy
Ospedale A Manzoni Withdrawn
Lecco, Italy
Slovakia
Nusch Completed
Bratislava, Slovakia
Vusch East Slovak Cardiology Institute Completed
Kosice, Slovakia
Spain
Hospital Clinic Provincial de Barcelona Completed
Barcelona, Spain
Hospital Ramón y Cajal Madrid Completed
Madrid, Spain
Switzerland
Kantonspital Luzern Completed
Luzern, Switzerland
University Hospital Zürich Completed
Zürich, Switzerland
Sponsors and Collaborators
Biotronik SE & Co. KG
Biotronik, Inc.
Investigators
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Study Chair: Antonio Curnis, Prof. Spedali Civili - Universita di Brescia, Italy
Study Chair: Mattias Roser, Dr. Charité CBF Berlin, Germany

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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02290028     History of Changes
Other Study ID Numbers: CR016
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: January 2019
Keywords provided by Biotronik SE & Co. KG:
CRT-D therapy
quadripolar left ventricular lead
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases