Cardiac ArrhythmiaRhytmiaPVCNCT03460535
The Rhytmia System to Determine the Precise Location and Potential Mechanism of Premature Contractions
An observational study of Cardiac Arrhythmia and Cardiomyopathy, Dilated, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This is a purely observational project and the objectives are to record and analyze the local potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia, Cardiomyopathy, Dilated
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2017to Jun 2019
- Phase
- Observational
- 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
Study population: Patients will be recruited by consultations, hospitalisations or referral by external doctors, in the department of Cardiology. This is a purely observational study. No power calculation will be needed due to the lack of comparisons.
Who may be able to join
- patients with symptomatic monomorphic PVC with or without heart disease refractory to anti arrhythmic drugs
- patients with dilated cardiomyopathy and altered Left Ventricular Ejection Fraction (LVEF) suspected to be causes by frequent monomorphic VPC
- patients with malignant ventricular arrhythmias reproducibly induced by monomorphic PVC
Who cannot join
- patients with non-symptomatic VPC and without cardiomyopathy
- patients under 18 yo
- pregnant women
- patients with polymorphic PVC arising from clearly different areas
- patient protected by the french law: guardianship and Trusteeship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Philippe Maury, MD, 5 61 32 30 54 ext. 33, maury.p@chu-toulouse.fr
Isabelle Olivier, PhD, 5 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Use of the Rhytmia System for Determining the Precise Location and Potential Mechanism of Premature Ventricular Contractions
This is a purely observational project and the objectives are to record and analyze the local potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard procedures, to highlight the advantages of the system compared to conventional mapping and to characterize optimal pace map or activation map as achieved by the Rhythmia system.
Read the detailed description
This is a purely observational study. No special methodology choice, no comparison.
The study want to find the determination of precise location of the focus and mechanisms involved constitutes a challenge for conventional electrophysiology, even with tridimensional systems, because of the time needed for accurate delineation of the location (due to the sometimes unfrequent Ventricular Premature Beats (VPB)) and to the insufficient mapping density or inadequate signal characteristics. The Rhythmia system could allow better determination of the focus location in relation to the anatomical structures, especially with unfrequent VPB, because of the available high density mapping due to the number of closed high-resolution electrodes located on the Orion catheter. Better delineation of the true focus origin and of the mechanisms involved (automaticity vs re-entry) may be of useful help for better understanding and efficient therapy.
- Conditions
- Cardiac Arrhythmia, Cardiomyopathy, Dilated
- Keywords
- Rythmia system
- Medical subject headings
- Arrhythmias, Cardiac, Cardiomyopathy, Dilated
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the surface of optimal pace map or activation map
To evaluate the area of isochronal earliest activation of PVC (Premature Ventricular Contraction), based on unipolar or bipolar activation : correlations will be made with the suspected endocardial or epicardial/intra-mural location of the focus. This technic may reduce the area of perfect pace-mapping and possibly more accurately locate the focus.
Measured: One year
Secondary outcomes (4)
Record the local potentials at the site of PVC focus through the Rhythmia system
Pacing from any electrode being in close contact with the endocardial surface and comparing the paced QRS to the spontaneous VPC (automatic calculation available on Bard ElectroPhysiology (EP) system).
Describe and analyze the local signals recorded from the Orion catheter at the site of the PVC focus.
by looking for prepotentials as a surrogate of local abnormal automaticity, for local discrete scar and local late potentials favouring local reentry as a cause for PVC, determining the local activation characteristics of VPC (surface of local breakthrough, velocity and direction of activation.
Measured: One year
Determine the short success of the procedure
Determine by repeated Holter recordings, and the relation to the findings made during the procedure (endocardial or suspected epicardial focus), mechanism
Measured: One year
Determine long-term success of the procedure and compare it to the existing
Determine by repeated Holter recordings, and the relation to the findings made during the procedure (endocardial or suspected epicardial focus), mechanism
Measured: One year
Characterize optimal pace map or activation map as achieved by the Rhythmia system
Evaluate the surface of perfect pace-mapping using the Orion catheter, by pacing from any electrode being in close contact with the endocardial surface and comparing the paced QRS to a template of the spontaneous VPC
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start14 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Philippe Maury, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460535
- Sponsor's protocol ID
- RC31/16/8916
- Other IDs
- 2017-A00777-46
- Acronym
- RhytmiaPVC
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 9 Mar 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 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Rhytmia System for Determining the Precise Location and Potential Mechanism of Premature Ventricular Contractions
- ClinicalTrials.gov ID
- NCT03460535
- Acronym / sponsor ID
- RhytmiaPVC / RC31/16/8916
- Conditions
- Cardiac Arrhythmia, Cardiomyopathy, Dilated
- Keywords
- Rythmia system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 9 Mar 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.
This is a purely observational project and the objectives are to record and analyze the local potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard procedures, to highlight the advantages of the system compared to conventional mapping and to characterize optimal pace map or activation map as achieved by the Rhythmia system.
Detailed description
This is a purely observational study. No special methodology choice, no comparison.
The study want to find the determination of precise location of the focus and mechanisms involved constitutes a challenge for conventional electrophysiology, even with tridimensional systems, because of the time needed for accurate delineation of the location (due to the sometimes unfrequent Ventricular Premature Beats (VPB)) and to the insufficient mapping density or inadequate signal characteristics. The Rhythmia system could allow better determination of the focus location in relation to the anatomical structures, especially with unfrequent VPB, because of the available high density mapping due to the number of closed high-resolution electrodes located on the Orion catheter. Better delineation of the true focus origin and of the mechanisms involved (automaticity vs re-entry) may be of useful help for better understanding and efficient therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited by consultations, hospitalisations or referral by external doctors, in the department of Cardiology. This is a purely observational study. No power calculation will be needed due to the lack of comparisons.
Key inclusion criteria (3 listed)
- patients with symptomatic monomorphic PVC with or without heart disease refractory to anti arrhythmic drugs
- patients with dilated cardiomyopathy and altered Left Ventricular Ejection Fraction (LVEF) suspected to be causes by frequent monomorphic VPC
- patients with malignant ventricular arrhythmias reproducibly induced by monomorphic PVC
Key exclusion criteria (5 listed)
- patients with non-symptomatic VPC and without cardiomyopathy
- patients under 18 yo
- pregnant women
- patients with polymorphic PVC arising from clearly different areas
- patient protected by the french law: guardianship and Trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the surface of optimal pace map or activation map
Time frame: One year
To evaluate the area of isochronal earliest activation of PVC (Premature Ventricular Contraction), based on unipolar or bipolar activation : correlations will be made with the suspected endocardial or epicardial/intra-mural location of the focus. This technic may reduce the area of perfect pace-mapping and possibly more accurately locate the focus.
4 secondary outcomes
Record the local potentials at the site of PVC focus through the Rhythmia system
Time frame: One year
Determine the short success of the procedure
Time frame: One year
Determine long-term success of the procedure and compare it to the existing
Time frame: One year
Characterize optimal pace map or activation map as achieved by the Rhythmia system
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmia
Not yet recruitingPhase 4
An Investigator-initiated, Prospective, Open-label, Multicenter Randomized Controlled Trial, Comparing the Efficacy of Sacubitril/Valsartan and Standard Treatment on Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients Without Hypertensive
Atrial Fibrillation (Persistent), Catheter Ablation
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
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.
Philippe Maury, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia and Cardiomyopathy, Dilated, run by University Hospital, Toulouse 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 3 inclusion and 5 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 Mar 2018. 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 Philippe Maury, MD (5 61 32 30 54 ext. 33, maury.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the surface of optimal pace map or activation map (time frame: One year). 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 9 Mar 2018.