ArrythmiaNCT02057588
Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
A study testing LV pacing site in people with Arrythmia, run by Abbott Medical Devices at 1 site in France.
Trial summary
The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia
- What is being tested?
- LV pacing site
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jun 2016
- 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 with SJM CRM device implanted for more than 90 days
Who cannot join
- Suspicion of lead dislodgment
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.
- Conditions
- Arrythmia
- Being tested
- LV pacing site
- Keywords
- ablation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV pacing siteProcedure or surgery
Patient will be paced in VVI mode from Left ventricle specific position for a short period of time per position in order to cover spontaneous ventricular activity
| Study group | Role | What they receive |
|---|---|---|
| LV Paced sites | Other | LV pacing sites : Patients will be paced from various left ventricular origin, defined by their 3D localization. Receives: Procedure: LV pacing site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method
Correlation coefficient between ventricular activation patterns determined by a traditional technique, 12-lead ECG based vs. device based IEGMs method.
Measured: Acute, intraoperative
Secondary outcomes (1)
Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping
Use of available IEGMs recorded on implanted device to discriminate specific VT origin and pattern and compare the results to the detailed mapping data
Measured: Acute, intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederic Sacher, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057588
- Sponsor's protocol ID
- CR-12-082-FR-HV
- Status last verified
- Apr 2022
- First submitted
- 31 Jan 2014
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
- ClinicalTrials.gov ID
- NCT02057588
- Acronym / sponsor ID
- CR-12-082-FR-HV
- Conditions
- Arrythmia
- Keywords
- ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Feb 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.
The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LV Paced sites | Other | Procedure: LV pacing siteLV pacing sites : Patients will be paced from various left ventricular origin, defined by their 3D localization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with SJM CRM device implanted for more than 90 days
Key exclusion criteria (1 listed)
- Suspicion of lead dislodgment
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 |
|---|---|---|
| LV pacing sitePatient will be paced in VVI mode from Left ventricle specific position for a short period of time per position in order to cover spontaneous ventricular activity | Procedure or surgery | LV Paced sites |
Primary outcome
Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method
Time frame: Acute, intraoperative
Correlation coefficient between ventricular activation patterns determined by a traditional technique, 12-lead ECG based vs. device based IEGMs method.
1 secondary outcome
Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping
Time frame: Acute, intraoperative
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 7 Apr 2022.
Related trials for Arrythmia
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Frederic Sacher, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LV pacing site in people with Arrythmia, run by Abbott Medical Devices at 1 site in France.
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 1 inclusion and 1 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 7 Apr 2022. 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 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?
Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method (time frame: Acute, intraoperative). 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 7 Apr 2022.