A Prospective Pilot Study (BIO|SELECT Pilot)
A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response
1 other identifier
observational
201
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2017
CompletedStudy Start
First participant enrolled
November 7, 2017
CompletedFirst Posted
Study publicly available on registry
November 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2019
CompletedJanuary 27, 2021
January 1, 2021
1.9 years
October 24, 2017
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters
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.
through study completion, an average of 7 months
Secondary Outcomes (2)
Rate of arrhythmia episodes
through study completion, an average of 7 months
Influence by baseline characteristics
through study completion, an average of 7 months
Eligibility Criteria
The patient collective consists of heart failure patients with CRT-D indication according to clinical routine. Two hundred patients with successful device implantation will be enrolled in the clinical investigation.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
November 9, 2017
Study Start
November 7, 2017
Primary Completion
October 7, 2019
Study Completion
October 7, 2019
Last Updated
January 27, 2021
Record last verified: 2021-01