Status:
COMPLETED
A Prospective Pilot Study (BIO|SELECT Pilot)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Eligibility:
All Genders
20+ years
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. The...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 7 2019
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03337763
Start Date
November 7 2017
End Date
October 7 2019
Last Update
January 27 2021
Active Locations (1)
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1
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611