Ventricular TachycardiaATLASNCT03611465
Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts
A study testing Pace-mapping and Standard pace-mapping examination in people with Ventricular Tachycardia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Pace-mapping and Standard pace-mapping examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2018to 26 Apr 2024
- 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
- Presenting one of these conditions :
- patients undergoing a VT ablation and myocardial infarction history
- patients with myocardial infarction history without VT history
- patients without myocardial infarction history but undergoing an invasive procedure in left atrium (atrial fibrillation or accessory pathway ablation)
Who cannot join
- pregnancy
- LVEF (left ventricular ejection fraction ) <20 %
- hemorrhagic stroke history
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54000
Claire DESSALE, +33383157823, cic-it-nancy@chru-nancy.fr
About this study
Aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease.
Read the detailed description
Ventricular tachycardia (VT) represent an important problem in western countries. 350 000 deaths are attributable to ventricular arrhythmias in Europe every year. The gold standard treatment is to implant a cardiac defibrillator that will be able to stop arrhythmia by delivering pacing or internal shocks.
In order to avoid internal shocks, ablation techniques have been developed, consisting in placing catheters in the left ventricle, to induce the VT, and then to perform a mapping of its circuit. Once this circuit is clearly defined, ablation of the critical part of the circuit, so called VT isthmus can be performed, using a radiofrequency power. One of the limitations of this technique is that it requires VT induction during the procedure, and that the VT lasts long enough to enable its mapping.
Nancy University Hospital developed a technique using pace mapping to define the VT isthmus even when the VT is not sustained. The pace mapping technique enables to reveal conduction troubles in the studied ventricles, that correspond with the VT isthmus.
During this study, the investigators will collect pace-mapping data from ventricles of patient presenting infarction history and VT, from patients with infarction history without VT, and from patients without ventricular pathology.
- Conditions
- Ventricular Tachycardia
- Being tested
- Pace-mapping, Standard pace-mapping examination
- Keywords
- Sudden cardiac death, Electrophysiologic exploration, Myocardial infarction
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pace-mappingOther
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.
Standard pace-mapping examinationOther
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.
| Study group | Role | What they receive |
|---|---|---|
| VT ablation group | Other | patients presenting history of myocardial infarction and ventricular tachycardia undergoing a VT ablation Receives: Other: Standard pace-mapping examination |
| pre implantation group | Experimental | patients presenting history of myocardial infarction but without history of ventricular tachycardia. Patients scheduled for a cardiac defibrillator implantation in primary prevention. Receives: Other: Pace-mapping |
| control group | Experimental | patients without history of myocardial infarction and without history of ventricular tachycardia, undergoing an ablation in the left atrium for an atrial fibrillation or an accessory pathway ablation. Receives: Other: Pace-mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete electrophysiology datasets for each group
Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during topo-stimulation.
Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during pace-mapping.
It will be considered complete if 100 measurement points have been acquired (pace-mapping and ECG), covering all 17 segments of the left ventricle.
Measured: the electrophysiological exploration is carried out the day after the patient's hospitalization and the datasets are generated just after removing the catheter from the patient, ie about 3 hours later the beginning of the exploration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start26 Oct 2018
- Primary completion26 Oct 2023 (estimated)
- Study completion26 Apr 2024 (estimated)
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 Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There is no randomization. Patients are provided into 3 groups according to their pathology.
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jean-Marc SELLAL, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611465
- Sponsor's protocol ID
- 2017-A01857-46
- Acronym
- ATLAS
- Status last verified
- Aug 2022
- First submitted
- 26 Mar 2018
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Chillou C, Groben L, Magnin-Poull I, Andronache M, MagdiAbbas M, Zhang N, Abdelaal A, Ammar S, Sellal JM, Schwartz J, Brembilla-Perrot B, Aliot E, Marchlinski FE. Localizing the critical isthmus of postinfarct ventricular tachycardia: the value of pace-mapping during sinus rhythm. Heart Rhythm. 2014 Feb;11(2):175-81. doi: 10.1016/j.hrthm.2013.10.042.
PubMed 24513915
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts
- ClinicalTrials.gov ID
- NCT03611465
- Acronym / sponsor ID
- ATLAS / 2017-A01857-46
- Conditions
- Ventricular Tachycardia
- Keywords
- Sudden cardiac death, Electrophysiologic exploration, Myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 26 Oct 2023 (estimated)
- Study completion
- 26 Apr 2024 (estimated)
- First posted
- 2 Aug 2018 (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.
Aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease.
Detailed description
Ventricular tachycardia (VT) represent an important problem in western countries. 350 000 deaths are attributable to ventricular arrhythmias in Europe every year. The gold standard treatment is to implant a cardiac defibrillator that will be able to stop arrhythmia by delivering pacing or internal shocks.
In order to avoid internal shocks, ablation techniques have been developed, consisting in placing catheters in the left ventricle, to induce the VT, and then to perform a mapping of its circuit. Once this circuit is clearly defined, ablation of the critical part of the circuit, so called VT isthmus can be performed, using a radiofrequency power. One of the limitations of this technique is that it requires VT induction during the procedure, and that the VT lasts long enough to enable its mapping.
Nancy University Hospital developed a technique using pace mapping to define the VT isthmus even when the VT is not sustained. The pace mapping technique enables to reveal conduction troubles in the studied ventricles, that correspond with the VT isthmus.
During this study, the investigators will collect pace-mapping data from ventricles of patient presenting infarction history and VT, from patients with infarction history without VT, and from patients without ventricular pathology.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There is no randomization. Patients are provided into 3 groups according to their pathology.
| Arm | Type | Receives |
|---|---|---|
| VT ablation group | Other | Other: Standard pace-mapping examinationpatients presenting history of myocardial infarction and ventricular tachycardia undergoing a VT ablation |
| pre implantation group | Experimental | Other: Pace-mappingpatients presenting history of myocardial infarction but without history of ventricular tachycardia. Patients scheduled for a cardiac defibrillator implantation in primary prevention. |
| control group | Experimental | Other: Pace-mappingpatients without history of myocardial infarction and without history of ventricular tachycardia, undergoing an ablation in the left atrium for an atrial fibrillation or an accessory pathway ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presenting one of these conditions :
- patients undergoing a VT ablation and myocardial infarction history
- patients with myocardial infarction history without VT history
- patients without myocardial infarction history but undergoing an invasive procedure in left atrium (atrial fibrillation or accessory pathway ablation)
Key exclusion criteria (3 listed)
- pregnancy
- LVEF (left ventricular ejection fraction ) <20 %
- hemorrhagic stroke history
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 |
|---|---|---|
| Pace-mappingAcquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction. | Other | control group, pre implantation group |
| Standard pace-mapping examinationAcquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction. | Other | VT ablation group |
Primary outcome
Complete electrophysiology datasets for each group
Time frame: the electrophysiological exploration is carried out the day after the patient's hospitalization and the datasets are generated just after removing the catheter from the patient, ie about 3 hours later the beginning of the exploration
Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during topo-stimulation. Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during pace-mapping. It will be considered complete if 100 measurement points have been acquired (pace-mapping and ECG), covering all 17 segments of the left ventricle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 24513915de Chillou C, Groben L, Magnin-Poull I, Andronache M, MagdiAbbas M, Zhang N, Abdelaal A, Ammar S, Sellal JM, Schwartz J, Brembilla-Perrot B, Aliot E, Marchlinski FE. Localizing the critical isthmus of postinfarct ventricular tachycardia: the value of pace-mapping during sinus rhythm. Heart Rhythm. 2014 Feb;11(2):175-81. doi: 10.1016/j.hrthm.2013.10.042.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pace-mapping and Standard pace-mapping examination in people with Ventricular Tachycardia, run by Central Hospital, Nancy, France 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 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc SELLAL (0033 3 83 15 32 56, jm.sellal@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete electrophysiology datasets for each group (time frame: the electrophysiological exploration is carried out the day after the patient's hospitalization and the datasets are generated just after removing the catheter from the patient, ie about 3 hours later the beginning of the exploration). 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 NCT03611465, 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 9 Aug 2022.