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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: Sentus QP left ventricular lead

• Study Type: Interventional
• Enrollment (Actual): 2226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Bedford Park, Australia
    • Flinders Medical Center
  • Elizabeth Vale, Australia
    • Lyell McEwing Hospital
  • Epping, Australia
    • The Northern Hospital
  • Hobart, Australia
    • Royal Hobart Hospital
  • Nambour, Australia
    • Nambour General Hospital
• Austria
  • Linz, Austria
    • AKh Linz
  • Wels, Austria
    • Klinikum Wels-Grieskirchen GmbH
  • Wien, Austria
    • AKH Wien
• Denmark
  • Hellerup, Denmark
    • Gentofte Hospital
  • Odense, Denmark
    • Odense Universitets Hospital
• Germany
  • Berlin, Germany
    • DHZ Berlin
  • Berlin, Germany
    • Maria Heimsuchung Caritas Klinik Pankow
  • Berlin, Germany
    • Virchow Klinikum
  • Bernau, Germany
    • Immanuel Klinikum Herzzentrum Bernau
  • Bielefeld, Germany
    • Städtisches Krankenhaus Bielefeld Mitte
  • Bochum, Germany
    • Augusta-Kranken-Anstalt Bochum
  • Düsseldorf, Germany
    • Augusta Krankenhaus Düsseldorf
  • Düsseldorf, Germany
    • Heinrich Heine University Düsseldorf
  • Erlangen, Germany
    • Universitätsklinik Erlangen
  • Essen, Germany
    • Elisabeth Krankenhaus Essen
  • Freiburg, Germany
    • UHZ Freiburg
  • Gera, Germany
    • SRH Wald-Klinikum Gera gGmbH
  • Kaiserslautern, Germany
    • Westpfalzklinikum
  • Leipzig, Germany
    • Städtisches Klinikum St. Georg
  • Lübeck, Germany
    • Uksh Campus Lubeck
  • Lünen, Germany
    • Marienhospital Lünen
  • Stade, Germany
    • Elbekliniken Stade - Buxtehude
  • Villingen, Germany
    • SBK Villingen Schwenningen
  • Völklingen, Germany
    • SHG-Kliniken Völklingen
  • Würzburg, Germany
    • Universitatsklinikum Wurzburg
  • Zwickau, Germany
    • HBK Zwickau
• Hungary
  • Budapest, Hungary
    • Semmelweis University
• Israel
  • Ashkelon, Israel
    • Barzilai Medical Center
  • Beer Sheva, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Rambam Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Center
• Italy
  • Brescia, Italy
    • Spedali Civili di Brescia
  • Como, Italy
    • Azienda Ospedaliero Sant'Anna Como
• Slovakia
  • Bratislava, Slovakia
    • NUSCH
  • Kosice, Slovakia
    • Vusch East Slovak Cardiology Institute
• Spain
  • Barcelona, Spain
    • Hospital Clinic Provincial De Barcelona
  • Madrid, Spain
    • Hospital Ramón y Cajal Madrid
• Switzerland
  • Luzern, Switzerland
    • Kantonspital Luzern
  • Zürich, Switzerland
    • University Hospital Zurich
• United States
  • Alabama
    • Fairhope, Alabama, United States
  • Alaska
    • Anchorage, Alaska, United States
  • California
    • Chula Vista, California, United States
    • Inglewood, California, United States
    • Rancho Mirage, California, United States
  • Colorado
    • Aurora, Colorado, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Orlando, Florida, United States, 32806
    • Orlando, Florida, United States, 32803
    • Pensacola, Florida, United States
    • Tampa, Florida, United States, 33613
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
    • Joliet, Illinois, United States
  • Indiana
    • Fort Wayne, Indiana, United States
  • Iowa
    • Iowa City, Iowa, United States
  • Kansas
    • Kansas City, Kansas, United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
    • Lexington, Kentucky, United States, 40503
  • Louisiana
    • New Orleans, Louisiana, United States
  • Maine
    • Bangor, Maine, United States
  • Massachusetts
    • Boston, Massachusetts, United States
    • Burlington, Massachusetts, United States
    • Fall River, Massachusetts, United States
    • Worcester, Massachusetts, United States
  • Michigan
    • Ann Arbor, Michigan, United States
    • Detroit, Michigan, United States
    • Ypsilanti, Michigan, United States
  • Mississippi
    • Tupelo, Mississippi, United States
  • Missouri
    • Kansas City, Missouri, United States
    • Saint Charles, Missouri, United States
    • Saint Louis, Missouri, United States, 63110
    • Saint Louis, Missouri, United States, 63136
    • Springfield, Missouri, United States
  • Montana
    • Kalispell, Montana, United States
  • New Jersey
    • Browns Mills, New Jersey, United States
    • Englewood, New Jersey, United States
    • Hackensack, New Jersey, United States
    • Neptune, New Jersey, United States
  • New York
    • Bronx, New York, United States
    • Brooklyn, New York, United States
    • Flushing, New York, United States
    • New York, New York, United States, 10016
    • New York, New York, United States, 10021
    • New York, New York, United States, 10025
    • New York, New York, United States, 10029
    • Valhalla, New York, United States
  • North Carolina
    • Asheville, North Carolina, United States
    • Chapel Hill, North Carolina, United States
    • Greensboro, North Carolina, United States
    • Greenville, North Carolina, United States
    • Winston-Salem, North Carolina, United States, 27103
    • Winston-Salem, North Carolina, United States, 27157
  • North Dakota
    • Fargo, North Dakota, United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
    • Columbus, Ohio, United States, 43214
    • Columbus, Ohio, United States, 43210
    • Toledo, Ohio, United States, 43615
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Wynnewood, Pennsylvania, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • South Carolina
    • Anderson, South Carolina, United States
    • Columbia, South Carolina, United States
    • Greenville, South Carolina, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
  • Texas
    • Amarillo, Texas, United States
    • Fort Worth, Texas, United States
    • San Antonio, Texas, United States
    • The Woodlands, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Vermont
    • Burlington, Vermont, United States
  • Virginia
    • Norfolk, Virginia, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States
  • Wyoming
    • Cheyenne, Wyoming, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sentus QP left ventricular lead; Subjects consented and implanted with a Sentus QP left ventricular lead.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sentus QP Acceptable Pacing Threshold in Permanently Programmed Vector at 3 Months Per Lead Model	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. This was evaluated as the number of participants with an acceptable pacing threshold out of the total number of patients for each lead model. LV threshold values of less than or equal to 2.5 V at 0.4 ms in the permanently programmed vector is considered acceptable.	3 months
Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months	The purpose of this secondary endpoint is to evaluate the number of participants with at least one acceptable LV lead pacing threshold in a novel pacing vector at 3 months post-implantation. This was evaluated as the number of participants with at least one acceptable LV pacing threshold in a novel pacing vector out of the total number of participants with completed novel pacing threshold testing. LV threshold values of less than or equal to 2.5 V at 0.4 ms in a novel pacing vector is considered acceptable.	3 months
Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model	The purpose of this secondary endpoint is to evaluate acceptable LV lead sensing amplitude at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV sensing amplitude out of the total number of participants. R-wave sensed mean amplitude of greater than or equal to 2 mV is considered acceptable.	3 months
Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model	The purpose of this secondary endpoint is to evaluate the acceptable LV lead pacing impedance at 3 months post-implantation. This was evaluated as the number of participants with an acceptable LV pacing impedance out of the total participants. LV impedance values of greater than 200 Ohms and less than 2000 Ohms is considered acceptable.	3 months
Sentus QP Time to Complication	The purpose of this secondary is to evaluate the Sentus related complication-free rate through 6 months post-implant by the Kaplan-Meier method. The below table shows Kaplan-Meier estimates of the estimated freedom from Sentus related complications at 180 days.	6 months
Sentus QP Related Complication-free Rate Per Lead Model	The purpose of secondary endpoint 7 is to evaluate the Sentus QP related complication-free rate through study termination (post approval phase). This is evaluated as percentage of participants without a complication per lead model.	Up to 4 years
Individual Sentus QP Adverse Event Rates	The purpose of secondary endpoint 8 is to evaluate the rate of individual types of adverse events related to the Sentus QP lead through study termination (post approval phase). This is evaluated as the percentage of participants with a specific adverse event out of the total participants.	Up to 4 years
Number of Participants Successfully Reprogrammed to Resolve Phrenic Nerve Stimulation or High Pacing Threshold	The purpose of this secondary endpoint is to evaluate the number of participants in whom phrenic nerve stimulation or high LV pacing threshold was be successfully resolved by reprogramming of the LV pacing vector. This is evaluated as the number of participants with successful reprogramming out of all participants experiencing phrenic nerve stimulation or high LV pacing threshold. LV pacing threshold resulting in invasive intervention, or, in the absence of intervention, a lead threshold that has increased two fold from the chronic threshold value, and is unable to achieve a 2:1 safety margin at follow-up is considered a high LV pacing threshold.	12 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Collaborators: Biotronik, Inc.
• Investigators: Study Chair: Antonio Curnis, Prof., Spedali Civili - Universita di Brescia, Italy; Study Chair: Mattias Roser, Dr., Charité CBF Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2014
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): January 23, 2020

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: CRT-D therapy; quadripolar left ventricular lead
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR016