Cardiac Rhythm DisordersCARRYNCT02647749
Non-invasive Mapping of Rhythm Disorders
A study testing Cardioinsight® mapping system and Conventional method without non-invasive mapping in people with Cardiac Rhythm Disorders, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This current care protocol follows the biomedical research protocol entitled "Non-invasive mapping of the heart ECG high amplification" that demonstrated the clinical value of noninvasive Cardioinsight® mapping system. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cardiac Rhythm Disorders
- What is being tested?
- Cardioinsight® mapping system and Conventional method without non-invasive mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2015to 28 May 2020
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Oral agreement of the patient or of the holder of parental responsibility after reading the informed consent form.
- Patients with the following 3 conditions :
- Ablation of drugs rebels arrhythmias.
- Or implantation or programming of a pacemaker (pacemaker or defibrillator)
- Or symptoms and / or cardiopathy with risk of sudden death.
Who cannot join
- Pregnancy and lactation.
- Patients unable to give oral agreement.
- Inconsistent patient's morphology with the establishment of the electrode jacket
Trial locations and contacts
1 site in 1 country.
About this study
This current care protocol follows the biomedical research protocol entitled "Non-invasive mapping of the heart ECG high amplification" that demonstrated the clinical value of noninvasive Cardioinsight® mapping system.
Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of serious arrhythmias or sudden death, with the currently used non-invasive mapping routine. The results obtained with non-invasive mapping will be compared with those obtained with the conventional method without non-invasive mapping.
Read the detailed description
This current care protocol is for 3 groups of patients :
- Role of mapping arrhythmias before radiofrequency ablation : Radiofrequency ablation is a treatment of atrial or ventricular arrhythmias resistant to drug treatment. The electrocardiogram does not allow a full diagnosis of arrhythmias and it appears difficult to get a comprehensive and simultaneous view of cardiac activity during invasive maps. The Investigators have demonstrated the feasibility of mapping atrial fibrillation and its usefulness to guide radiofrequency ablation. The non-invasive mapping would allow a better understanding of complex cardiac arrhythmias mechanism (atrial fibrillation, ventricular tachycardia and ventricular fibrillation in particular), would identify the arrhythmogenic sites and thus facilitate radiofrequency ablation.
- Optimizing the site of implantation of cardiac pacing leads and programming the pacemaker: The optimal position of the cardiac pacing leads may vary from one patient to another and the current choice of implantation sites is essentially guided by imaging and does not use power requirements because of the inadequacies of the ECG standard. The Investigators have already demonstrated the usefulness of non-invasive mapping in the selection of potential responders to cardiac resynchronization therapy. The non-invasive mapping would study the cardiac electrical activation in order to determine the optimal pacing sites and optimum programming according to each patient and thus improve the clinical response to pacing.
- Role diagnostic and prognostic for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death :
The possibility to identify electrically abnormal areas either during the activation, or during cardiac repolarization with the high-resolution ECG is an indication of myocardial pathology that can be both unapparent on standard ECG and inaccessible to imaging techniques (ultrasound, CT or MRI). It is likely that such electrical anomalies are early diagnostic features of heart disease that will later be apparent. Such anomalies can also have an adverse prognostic weight (risk of arrhythmias or sudden death) that can be corrected if it is highlighted. Non-invasive mapping seems particularly important in patients with unexplained symptoms by conventional tests (palpitations or discomfort - syncope). It will also be applicable to patients with heart disease (myocardial infarction, cardiomyopathy) in search of localized electrical disorders that can be an originating site of arrhythmia.
- Conditions
- Cardiac Rhythm Disorders
- Being tested
- Cardioinsight® mapping system, Conventional method without non-invasive mapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardioinsight® mapping systemDevice
Conventional method without non-invasive mappingOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Cardiac rythm radiofrequency ablation | Experimental | Prospective recruitment Receives: Device: Cardioinsight® mapping system |
| Group 1: Implantation or programming of a pacemaker | Experimental | Prospective recruitment Receives: Device: Cardioinsight® mapping system |
| Group 1: Risk of serious arrhythmias or sudden death | Experimental | Prospective recruitment Receives: Device: Cardioinsight® mapping system |
| Group 2: Cardiac rythm radiofrequency ablation | Active comparator | Retrospective recruitment Receives: Other: Conventional method without non-invasive mapping |
| Group 2 : Implantation or programming of a pacemaker | Active comparator | Retrospective recruitment Receives: Other: Conventional method without non-invasive mapping |
| Group 2 : Risk of serious arrhythmias or sudden death | Active comparator | Retrospective recruitment Receives: Other: Conventional method without non-invasive mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia termination during ablation guided by the Cardioinsight® mapping system
Measured: Day 1
Variation of dP/dT measurement between baseline and after implantation or programmation of a pacemaker guided by the Cardioinsight® mapping system
In mmHg/s
Measured: Day 1
Measurement of the activation-recovery interval defined as the interval between a local depolarization time and repolarization time for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death
In ms
Measured: Day 1
Secondary outcomes (4)
Arrhythmia recurrence at 1 year after ablation guided by the Cardioinsight® mapping system
Measured: Year 1
For patients referred for implantation or programming of a pacemaker: Comparison of 6 Minutes Walk Test performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
In meters
Measured: Month 6
For patients referred for implantation or programming of a pacemaker: Comparison of left ventricular ejection fraction performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
In percentage
Measured: Month 6
Occurence of syncope, aborted sudden death or sudden death during follow-up for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death
Measured: Year 1, year 4 at most
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start19 May 2015
- Primary completionMay 2019
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Rhythm DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel HAÏSSAGUERRE, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647749
- Sponsor's protocol ID
- CHUBX 2015/01
- Acronym
- CARRY
- Status last verified
- Feb 2022
- First submitted
- 5 Nov 2015
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang J, Hocini M, Strom M, Cuculich PS, Cooper DH, Sacher F, Haissaguerre M, Rudy Y. The Electrophysiological Substrate of Early Repolarization Syndrome: Noninvasive Mapping in Patients. JACC Clin Electrophysiol. 2017 Aug;3(8):894-904. doi: 10.1016/j.jacep.2016.12.017.
PubMed 29130071
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Mapping of Rhythm Disorders
- ClinicalTrials.gov ID
- NCT02647749
- Acronym / sponsor ID
- CARRY / CHUBX 2015/01
- Conditions
- Cardiac Rhythm Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 May 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 6 Jan 2016 (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.
This current care protocol follows the biomedical research protocol entitled "Non-invasive mapping of the heart ECG high amplification" that demonstrated the clinical value of noninvasive Cardioinsight® mapping system.
Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of serious arrhythmias or sudden death, with the currently used non-invasive mapping routine. The results obtained with non-invasive mapping will be compared with those obtained with the conventional method without non-invasive mapping.
Detailed description
This current care protocol is for 3 groups of patients :
- Role of mapping arrhythmias before radiofrequency ablation : Radiofrequency ablation is a treatment of atrial or ventricular arrhythmias resistant to drug treatment. The electrocardiogram does not allow a full diagnosis of arrhythmias and it appears difficult to get a comprehensive and simultaneous view of cardiac activity during invasive maps. The Investigators have demonstrated the feasibility of mapping atrial fibrillation and its usefulness to guide radiofrequency ablation. The non-invasive mapping would allow a better understanding of complex cardiac arrhythmias mechanism (atrial fibrillation, ventricular tachycardia and ventricular fibrillation in particular), would identify the arrhythmogenic sites and thus facilitate radiofrequency ablation.
- Optimizing the site of implantation of cardiac pacing leads and programming the pacemaker: The optimal position of the cardiac pacing leads may vary from one patient to another and the current choice of implantation sites is essentially guided by imaging and does not use power requirements because of the inadequacies of the ECG standard. The Investigators have already demonstrated the usefulness of non-invasive mapping in the selection of potential responders to cardiac resynchronization therapy. The non-invasive mapping would study the cardiac electrical activation in order to determine the optimal pacing sites and optimum programming according to each patient and thus improve the clinical response to pacing.
- Role diagnostic and prognostic for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death :
The possibility to identify electrically abnormal areas either during the activation, or during cardiac repolarization with the high-resolution ECG is an indication of myocardial pathology that can be both unapparent on standard ECG and inaccessible to imaging techniques (ultrasound, CT or MRI). It is likely that such electrical anomalies are early diagnostic features of heart disease that will later be apparent. Such anomalies can also have an adverse prognostic weight (risk of arrhythmias or sudden death) that can be corrected if it is highlighted. Non-invasive mapping seems particularly important in patients with unexplained symptoms by conventional tests (palpitations or discomfort - syncope). It will also be applicable to patients with heart disease (myocardial infarction, cardiomyopathy) in search of localized electrical disorders that can be an originating site of arrhythmia.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Cardiac rythm radiofrequency ablation | Experimental | Device: Cardioinsight® mapping systemProspective recruitment |
| Group 1: Implantation or programming of a pacemaker | Experimental | Device: Cardioinsight® mapping systemProspective recruitment |
| Group 1: Risk of serious arrhythmias or sudden death | Experimental | Device: Cardioinsight® mapping systemProspective recruitment |
| Group 2: Cardiac rythm radiofrequency ablation | Active comparator | Other: Conventional method without non-invasive mappingRetrospective recruitment |
| Group 2 : Implantation or programming of a pacemaker | Active comparator | Other: Conventional method without non-invasive mappingRetrospective recruitment |
| Group 2 : Risk of serious arrhythmias or sudden death | Active comparator | Other: Conventional method without non-invasive mappingRetrospective recruitment |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Oral agreement of the patient or of the holder of parental responsibility after reading the informed consent form.
- Patients with the following 3 conditions :
- Ablation of drugs rebels arrhythmias.
- Or implantation or programming of a pacemaker (pacemaker or defibrillator)
- Or symptoms and / or cardiopathy with risk of sudden death.
Key exclusion criteria (3 listed)
- Pregnancy and lactation.
- Patients unable to give oral agreement.
- Inconsistent patient's morphology with the establishment of the electrode jacket
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 |
|---|---|---|
| Cardioinsight® mapping system | Device | Group 1 : Cardiac rythm radiofrequency ablation, Group 1: Implantation or programming of a pacemaker, Group 1: Risk of serious arrhythmias or sudden death |
| Conventional method without non-invasive mapping | Other | Group 2 : Implantation or programming of a pacemaker, Group 2 : Risk of serious arrhythmias or sudden death, Group 2: Cardiac rythm radiofrequency ablation |
Primary outcome
Arrhythmia termination during ablation guided by the Cardioinsight® mapping system
Time frame: Day 1
Variation of dP/dT measurement between baseline and after implantation or programmation of a pacemaker guided by the Cardioinsight® mapping system
Time frame: Day 1
In mmHg/s
Measurement of the activation-recovery interval defined as the interval between a local depolarization time and repolarization time for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death
Time frame: Day 1
In ms
4 secondary outcomes
Arrhythmia recurrence at 1 year after ablation guided by the Cardioinsight® mapping system
Time frame: Year 1
For patients referred for implantation or programming of a pacemaker: Comparison of 6 Minutes Walk Test performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
Time frame: Month 6
For patients referred for implantation or programming of a pacemaker: Comparison of left ventricular ejection fraction performed before and 6 months after implantation and/or programmation guided by the Cardioinsight® mapping system
Time frame: Month 6
Occurence of syncope, aborted sudden death or sudden death during follow-up for patients referred for evaluation of the risk of occurrence of a serious rhythm disorder or sudden death
Time frame: Year 1, year 4 at most
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 14 May 2026.
- Results publication: PubMed 29130071Zhang J, Hocini M, Strom M, Cuculich PS, Cooper DH, Sacher F, Haissaguerre M, Rudy Y. The Electrophysiological Substrate of Early Repolarization Syndrome: Noninvasive Mapping in Patients. JACC Clin Electrophysiol. 2017 Aug;3(8):894-904. doi: 10.1016/j.jacep.2016.12.017.
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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.
Michel HAÏSSAGUERRE, Pr 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 Cardioinsight® mapping system and Conventional method without non-invasive mapping in people with Cardiac Rhythm Disorders, run by University Hospital, Bordeaux 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 5 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 14 May 2026. 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?
Arrhythmia termination during ablation guided by the Cardioinsight® mapping system (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647749, which also lists 1 linked publication.
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 14 May 2026.