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A Prospective Pilot Study (BIO|SELECT Pilot)

Sponsor
Biotronik SE & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT03337763
Collaborator
(none)
201
Enrollment
1
Location
23
Actual Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular pacing mode. They are followed up by seven month post implantation, and predefined cardiac functional parameters are collected at each visit.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Enrolled patients will undergo the baseline medical tests to assess the cardiac functions (e.g. echo, blood test, and 12-Lead ECG) prior to the implantation of Biotronik CRT-D and QP lead featured with MultiPole Pacing parameter. At implantation, LV-LV conduction delays are measured in predefined LV pacing and sensing configurations. One month after the successful implantation, the patients revisit the investigation site to be adjudicated for programming MultiPole pacing or continuing bi-ventricular pacing mode, based on their echo readings by then. Patients are subsequently followed up at four and seven month post implantation to acquire the LV-LV conduction delays and echo readings, etc. at the time.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    201 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response
    Actual Study Start Date :
    Nov 7, 2017
    Actual Primary Completion Date :
    Oct 7, 2019
    Actual Study Completion Date :
    Oct 7, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters [through study completion, an average of 7 months]

      LV-LV/RV-LV intra-cardiac conduction time will be obtained at each time frame, and correlation will be investigated with variation of multiple hemodynamic parameters from baseline up to seven month follow up.

    Secondary Outcome Measures

    1. Rate of arrhythmia episodes [through study completion, an average of 7 months]

      Comparison between patient groups in terms of rate of arrhythmia

    2. Influence by baseline characteristics [through study completion, an average of 7 months]

      An alanysis of the impact of the baseline characteristics on other outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    To be eligible for the study enrollment, candidate patients must meet all of the following criteria

    • Indicated for a CRT-D implantation

    • Has never received CRT

    • Planned to be implanted with a quadripolar LV Lead, and CRT-D with MultiPole pacing feature, both manufactured by BIOTRONIK

    • Geographically stable and willing to comply with the required follow-up schedule

    • With written informed consent

    Exclusion Criteria:

    Candidate patients will not be eligible if either of the following criteria is applicable

    • Underwent a cardiac surgery within last 3 months, or scheduled for cardiac surgery other than CRT implantation

    • Life expectancy is less than a year

    • Can not be programmed to MultiPole pacing "ON"

    • Does not agree to the concept of HomeMonitoring System

    • With known pregnancy

    • At age below 20 years

    • Participated in another interventional clinical study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyorin University Hospital Mitaka Tokyo Japan 181-8611

    Sponsors and Collaborators

    • Biotronik SE & Co. KG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biotronik SE & Co. KG
    ClinicalTrials.gov Identifier:
    NCT03337763
    Other Study ID Numbers:
    • CR023
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    Jan 27, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Biotronik SE & Co. KG
    LV-LV conduction delay
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jan 27, 2021