- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03337763
A Prospective Pilot Study (BIO|SELECT Pilot)
January 26, 2021 updated by: Biotronik SE & Co. KG
A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
201
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Mitaka, Tokyo, Japan, 181-8611
- Kyorin University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of arrhythmia episodes
Time Frame: through study completion, an average of 7 months
|
Comparison between patient groups in terms of rate of arrhythmia
|
through study completion, an average of 7 months
|
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
|
through study completion, an average of 7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2017
Primary Completion (Actual)
October 7, 2019
Study Completion (Actual)
October 7, 2019
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
November 8, 2017
First Posted (Actual)
November 9, 2017
Study Record Updates
Last Update Posted (Actual)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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