Skip to main content
OpenTrials
Completed

NCT Number: NCT03337763

A Prospective Pilot Study (BIO|SELECT Pilot)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters

    Time frame: 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 outcomes

  1. Rate of arrhythmia episodes

    Time frame: through study completion, an average of 7 months

    Comparison between patient groups in terms of rate of arrhythmia

  2. Influence by baseline characteristics

    Time frame: through study completion, an average of 7 months

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

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.