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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 : Terminated (BIOTRONIK received FDA approval to transition the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.)
First Posted : November 13, 2014
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Tracking Information
First Submitted Date  ICMJE November 10, 2014
First Posted Date  ICMJE November 13, 2014
Results First Submitted Date  ICMJE January 25, 2021
Results First Posted Date  ICMJE March 24, 2021
Last Update Posted Date March 24, 2021
Actual Study Start Date  ICMJE December 16, 2014
Actual Primary Completion Date January 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
  • 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. This is evaluated as a percentage of participants without a complication.
  • Percentage of Participants 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.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.
  • Sentus QP Related Complication-free Rate [ Time Frame: Up to 4 years ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
  • Sentus QP Acceptable 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. 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.
  • Sentus QP Acceptable Pacing Threshold in Novel Vectors at 3 Months [ Time Frame: 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.
  • Sentus QP Acceptable R-wave Sensed Amplitude at 3 Months Per Lead Model [ Time Frame: 3 months ]
    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.
  • Sentus QP Acceptable Pacing Impedance at 3 Months Per Lead Model [ Time Frame: 3 months ]
    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.
  • Sentus QP Time to 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. The below table shows Kaplan-Meier estimates of the estimated freedom from Sentus related complications at 180 days.
  • Sentus QP Related Complication-free Rate Per Lead Model [ Time Frame: Up to 4 years ]
    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.
  • Individual Sentus QP Adverse Event Rates [ Time Frame: Up to 4 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 study termination (post approval phase). This is evaluated as the percentage of participants with a specific adverse event out of the total participants.
  • Number of Participants 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 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
Official Title  ICMJE Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Heart Failure
Intervention  ICMJE 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
Study Arms  ICMJE Sentus QP left ventricular lead
Subjects consented and implanted with a Sentus QP left ventricular lead.
Intervention: Device: Sentus QP left ventricular lead
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 1, 2021)
2226
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2014)
444
Actual Study Completion Date  ICMJE January 23, 2020
Actual Primary Completion Date January 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Denmark,   Germany,   Hungary,   Israel,   Italy,   Slovakia,   Spain,   Switzerland,   United States
Removed Location Countries Poland,   Portugal
 
Administrative Information
NCT Number  ICMJE NCT02290028
Other Study ID Numbers  ICMJE CR016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotronik SE & Co. KG
Study Sponsor  ICMJE Biotronik SE & Co. KG
Collaborators  ICMJE Biotronik, Inc.
Investigators  ICMJE
Study Chair: Antonio Curnis, Prof. Spedali Civili - Universita di Brescia, Italy
Study Chair: Mattias Roser, Dr. Charité CBF Berlin, Germany
PRS Account Biotronik SE & Co. KG
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP