Heart FailureBIO|PULSENCT03314675
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
A study testing BIOTRONIK CRT-D in people with Heart Failure, run by Biotronik SE & Co. KG at 7 sites in 3 countries.
Trial summary
The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- BIOTRONIK CRT-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 26 Feb 2018to 6 Jul 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
- Patient successfully implanted with a left ventricular lead
- High likelihood of LV latency ≥ 40 ms
- LV lead in lateral or postero-lateral position in the coronary venous system
- Patient is able to understand the nature of the clinical investigation
- Patient is willing to undergo the required measurements at the investigation site
- Patient provides written informed consent
- Age ≥ 18 years
Who cannot join
- Patients with irregular ventricular rhythm due to atrial tachycardia
- Pregnant or breast-feeding women
- Participation in an interventional clinical investigation
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Germany4 sites
Herz- und Diabetiszentrum NRW
Bad Oeynhausen, 32545
SRH Waldklinikum Gera GmbH
Gera
Universitätsklinikum Gießen und Marburg
Giessen, 35392
Universitätsklinikum Würzburg
Würzburg, 97080
Czechia2 sites
Ceske Budejovice hospital
České Budějovice, 37001
Institute for Clinical and Experimental Medicine
Prague, 14021
About this study
The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data
- Conditions
- Heart Failure
- Being tested
- BIOTRONIK CRT-D
- Keywords
- CRT-D, LV Latency
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOTRONIK CRT-DDevice
Pre-specified follow-up and measurements
| Study group | Role | What they receive |
|---|---|---|
| CRT-D Measurements | Other | Pre-specified measurements and additional follow-ups Receives: Device: BIOTRONIK CRT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
Measured: 1 day
Secondary outcomes (4)
Device-base measured LV latency in the LV IEGM channel and Far Field channel
Measured: 1 day
12-lead ECG-measured LV latency in the channel with earliest QRS onset
Measured: 1 day
Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel
Measured: 1 day
12-lead ECG-measured latency intervals
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start26 Feb 2018
- Primary completion28 Jun 2018
- Study completion6 Jul 2018
Why it stopped: Unsuccessful enrollment
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Nordbeck, PD Dr., Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314675
- Sponsor's protocol ID
- CR022
- Acronym
- BIO|PULSE
- Status last verified
- Nov 2018
- First submitted
- 16 Oct 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients
- ClinicalTrials.gov ID
- NCT03314675
- Acronym / sponsor ID
- BIO|PULSE / CR022
- Conditions
- Heart Failure
- Keywords
- CRT-D, LV Latency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsuccessful enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 19 Oct 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.
The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT-D Measurements | Other | Device: BIOTRONIK CRT-DPre-specified measurements and additional follow-ups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
- Patient successfully implanted with a left ventricular lead
- High likelihood of LV latency ≥ 40 ms
- LV lead in lateral or postero-lateral position in the coronary venous system
- Patient is able to understand the nature of the clinical investigation
Key exclusion criteria (3 listed)
- Patients with irregular ventricular rhythm due to atrial tachycardia
- Pregnant or breast-feeding women
- Participation in an interventional clinical investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOTRONIK CRT-DPre-specified follow-up and measurements | Device | CRT-D Measurements |
Primary outcome
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients
Time frame: 1 day
4 secondary outcomes
Device-base measured LV latency in the LV IEGM channel and Far Field channel
Time frame: 1 day
12-lead ECG-measured LV latency in the channel with earliest QRS onset
Time frame: 1 day
Device-based measured latency intervals (stimulus to electrogram peak and end) in the LV IEGM channel and the Far Field channel
Time frame: 1 day
12-lead ECG-measured latency intervals
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Unsuccessful enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Peter Nordbeck, PD Dr. principal investigator
Wuerzburg University Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOTRONIK CRT-D in people with Heart Failure, run by Biotronik SE & Co. KG at 7 sites in 3 countries.
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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Czechia, Netherlands. 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 was stopped early (reason given: Unsuccessful enrollment). Results are not available in the source record.
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?
Rate of patients with LV latency >/= 40ms (stimulus to QRS onset) with respect to the total number of screened patients (time frame: 1 day). 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 28 Nov 2018.