Cardiac ArrhythmiasE20PCNCT02326519
Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
A study testing Intracardiac electrode catheter in people with Cardiac Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in 2 countries.
Trial summary
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- Intracardiac electrode catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2013to 13 Mar 2015
- 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
- Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted
- Subjects who are undergoing a cardiac procedure where routine placement of cardiac catheter can be performed
- Subjects are willing to provide Informed Consent
Who cannot join
- • Subject has exclusion criteria per local law and regulations (e.g. age, breast feeding, etc)
- Any condition which precludes the subject's ability to comply with the study requirements
- Subject has physical conditions that contraindicate the use of the device per approved labeling, including but not limited to active sepsis, known sensitivity to heparin, cannot undergo standard anticoagulation protocol for cardiac procedure, blood clotting abnormalities or a recent coagulopathy or embolic event, venous filtering device (Greenfield Filter) and obstructed or damaged vessel
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.
Read the detailed description
The purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (EP study, pacemaker/ICD/CRT implant). To collect these signals, a 20 pole catheter (Medtronic StableMapr intracardiac steerable electrode catheter) will be acutely placed in the RV apex during a routine cardiac procedure.
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.
- Conditions
- Cardiac Arrhythmias
- Being tested
- Intracardiac electrode catheter
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac electrode catheterOther
All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter
| Study group | Role | What they receive |
|---|---|---|
| Intracardiac electrode catheter | Other | All patient in the study will have same data collected during the procedure using the Steerable intracardiac electrode catheter. Receives: Other: Intracardiac electrode catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The electrical signal mean amplitude (mv) during AV synchronous pacing.
Measured: 2 minutes during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study start1 Oct 2013
- Primary completion13 Jan 2015
- Study completion13 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326519
- Sponsor's protocol ID
- E20PC study
- Acronym
- E20PC
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2014
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
- ClinicalTrials.gov ID
- NCT02326519
- Acronym / sponsor ID
- E20PC / E20PC study
- Conditions
- Cardiac Arrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 13 Jan 2015 (actual)
- Study completion
- 13 Mar 2015 (actual)
- First posted
- 29 Dec 2014 (estimated)
- 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.
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.
Detailed description
The purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (EP study, pacemaker/ICD/CRT implant). To collect these signals, a 20 pole catheter (Medtronic StableMapr intracardiac steerable electrode catheter) will be acutely placed in the RV apex during a routine cardiac procedure.
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracardiac electrode catheter | Other | Other: Intracardiac electrode catheterAll patient in the study will have same data collected during the procedure using the Steerable intracardiac electrode catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted
Key exclusion criteria (3 listed)
- • Subject has exclusion criteria per local law and regulations (e.g. age, breast feeding, etc)
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 |
|---|---|---|
| Intracardiac electrode catheterAll patient in the study will have the same data collected using the Steerable intracardiac electrode catheter | Other | Intracardiac electrode catheter |
Primary outcome
The electrical signal mean amplitude (mv) during AV synchronous pacing.
Time frame: 2 minutes during the procedure
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 20 Dec 2017.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracardiac electrode catheter in people with Cardiac Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in 2 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 3 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: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, France. 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?
The electrical signal mean amplitude (mv) during AV synchronous pacing. (time frame: 2 minutes during the procedure). 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 20 Dec 2017.