Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

NCT02290028 | Terminated Results DMC

• 1 other identifier: CR016
• Study Type: interventional
• Target: 2,226
• Locations: 10 countries
• Sites: 114

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). 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

Heart Failure

Keywords

CRT-D therapy; quadripolar left ventricular lead

Outcome Measures

Primary Outcomes (3)

• Sentus QP Related Complication-free Rate Through 6 Months

  The purpose of primary endpoint 1 is to evaluate the Sentus QP related complication-free rate through 6 months post-implant. This is evaluated as a percentage of participants without a complication.

  6 months

• Percentage of Participants With Acceptable Pacing Threshold of Sentus QP Lead in Permanently Programmed Vector at 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.This was evaluated by performing an exact, binomial test comparing the percentage of participants with acceptable pacing thresholds to a performance goal of 88%. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector are considered acceptable.

  3 months

• Sentus QP Related Complication-free Rate

  The purpose of primary endpoint 3 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as a percentage of participants without a complication.

  Up to 4 years

Secondary Outcomes (8)

• Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model

  3 months

• Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months

  3 months

• Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model

  3 months

• Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model

  3 months

• Sentus QP Time to Complication

  6 months

Study Arms (1)

Sentus QP left ventricular lead

OTHER

Subjects consented and implanted with a Sentus QP left ventricular lead.

Device: Sentus QP left ventricular lead

Interventions

Sentus QP left ventricular lead DEVICE

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

Also known as: Sentus OTW QP L, Sentus OTW QP S, Sentus OTW QP S-xx/49, Sentus OTW QP L-xx/49

Sentus QP left ventricular lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chronic atrial fibrillation
• 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
• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead
• Biotronik, Inc.: collaborator

Study Sites (119)

Unknown Facility

Fairhope, Alabama, United States

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Anchorage, Alaska, United States

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Chula Vista, California, United States

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Inglewood, California, United States

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Rancho Mirage, California, United States

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Aurora, Colorado, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32806, United States

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Pensacola, Florida, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Fort Wayne, Indiana, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, 40503, United States

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Lexington, Kentucky, 40536, United States

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New Orleans, Louisiana, United States

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Bangor, Maine, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Fall River, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Ypsilanti, Michigan, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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Saint Charles, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63136, United States

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Kalispell, Montana, United States

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Browns Mills, New Jersey, United States

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Englewood, New Jersey, United States

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Hackensack, New Jersey, United States

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Neptune City, New Jersey, United States

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Brooklyn, New York, United States

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Flushing, New York, United States

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New York, New York, 10016, United States

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New York, New York, 10021, United States

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New York, New York, 10025, United States

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New York, New York, 10029, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, 27103, United States

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Winston-Salem, North Carolina, 27157, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43214, United States

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Toledo, Ohio, 43615, United States

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Bryn Mawr, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Amarillo, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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The Woodlands, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Norfolk, Virginia, United States

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Milwaukee, Wisconsin, United States

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Cheyenne, Wyoming, United States

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Flinders Medical Center

Bedford Park, Australia

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Lyell McEwing Hospital

Elizabeth Vale, Australia

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The Northern Hospital

Epping, Australia

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Royal Hobart Hospital

Hobart, Australia

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Nambour General Hospital

Nambour, Australia

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AKH Linz

Linz, Austria

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AKH Wien

Vienna, Austria

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Klinikum Wels-Grieskirchen GmbH

Wels, Austria

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Gentofte Hospital

Hellerup, Denmark

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Odense Universitets Hospital

Odense, Denmark

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DHZ Berlin

Berlin, Germany

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Maria Heimsuchung Caritas Klinik Pankow

Berlin, Germany

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Virchow Klinikum

Berlin, Germany

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Immanuel Klinikum Herzzentrum Bernau

Bernau, Germany

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Städtisches Krankenhaus Bielefeld Mitte

Bielefeld, Germany

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Augusta-Kranken-Anstalt Bochum

Bochum, Germany

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Augusta Krankenhaus Düsseldorf

Düsseldorf, Germany

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Heinrich Heine University Düsseldorf

Düsseldorf, Germany

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Universitätsklinik Erlangen

Erlangen, Germany

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Elisabeth Krankenhaus Essen

Essen, Germany

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UHZ Freiburg

Freiburg im Breisgau, Germany

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SRH Wald-Klinikum Gera gGmbH

Gera, Germany

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Westpfalzklinikum

Kaiserslautern, Germany

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Städtisches Klinikum St. Georg

Leipzig, Germany

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UKSH Campus Lübeck

Lübeck, Germany

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Marienhospital Lünen

Lünen, Germany

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Elbekliniken Stade - Buxtehude

Stade, Germany

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SBK Villingen Schwenningen

Villingen, Germany

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SHG-Kliniken Völklingen

Völklingen, Germany

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Universitätsklinikum Würzburg

Würzburg, Germany

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HBK Zwickau

Zwickau, Germany

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Semmelweis University

Budapest, Hungary

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Barzilai Medical Center

Ashkelon, Israel

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Soroka Medical Center

Beersheba, Israel

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Rambam Medical Center

Haifa, Israel

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Hadassah Medical Center

Jerusalem, Israel

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Spedali Civili di Brescia

Brescia, Italy

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Azienda Ospedaliero Sant'Anna Como

Como, Italy

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Nusch

Bratislava, Slovakia

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Vusch East Slovak Cardiology Institute

Košice, Slovakia

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Hospital Clinic Provincial de Barcelona

Barcelona, Spain

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Hospital Ramón y Cajal Madrid

Madrid, Spain

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Kantonspital Luzern

Lucerne, Switzerland

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University Hospital Zürich

Zurich, Switzerland

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Senior Manager, Scientific Affairs
• Organization: BIOTRONIK, Inc.

crystal.miller@biotronik.com

1-800-547-0394

Study Officials

• Antonio Curnis, Prof.

  Spedali Civili - Universita di Brescia, Italy

  STUDY CHAIR

• Mattias Roser, Dr.

  Charité CBF Berlin, Germany

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: December 16, 2014
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2020-01

Locations

AU (3); IT (2); IL (4); US (75); SL (2); DE (21); HU (1); CH (2); DK (2); ES (2)