Heart FailureNCT03337763
A Prospective Pilot Study (BIO|SELECT Pilot)
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 201 participants
- Where
- 1 siteJapan
- Study dates
- 7 Nov 2017to 7 Oct 2019
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read 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 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.
- Conditions
- Heart Failure
- Keywords
- LV-LV conduction delay
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 7 months
Secondary outcomes (2)
Rate of arrhythmia episodes
Comparison between patient groups in terms of rate of arrhythmia
Measured: through study completion, an average of 7 months
Influence by baseline characteristics
An alanysis of the impact of the baseline characteristics on other outcomes
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start7 Nov 2017
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337763
- Sponsor's protocol ID
- CR023
- Status last verified
- Jan 2021
- First submitted
- 24 Oct 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response
- ClinicalTrials.gov ID
- NCT03337763
- Acronym / sponsor ID
- CR023
- Conditions
- Heart Failure
- Keywords
- LV-LV conduction delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Rate of arrhythmia episodes
Time frame: through study completion, an average of 7 months
Influence by baseline characteristics
Time frame: through study completion, an average of 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters (time frame: through study completion, an average of 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.