An observational study in Cardiac Arrhythmia and Cardiomyopathy, Dilated, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by University Hospital, Toulouse · Observational
Among 85 studies in Arrhythmias, Cardiac with a site in France — 18 open to participants now, 23 under way, none of them phase 3. Arrhythmias, Cardiac · France.
Among the 85 studies in Arrhythmias, Cardiac with a site in France, this one is the 41st largest by planned enrollment of the 43 observational ones that give a count, is one of 5 that started in 2017, is one of 43 observational ones, and was the 39th registered.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
Browse Arrhythmias, Cardiac studies →18 of the 85 studies in Arrhythmias, Cardiac with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire Dijon · Sites in France
Ages 18+
Volta Medical · Sites in France
Ages 18+
Biotronik, Inc. · Sites in France, United States, Australia and 5 more countries
Ages 18+
Groupe Hospitalier Pitie-Salpetriere · Sites in France
Healthy volunteers
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 15+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 167 Arrhythmias, Cardiac studies recruiting now, 118 (71%) set no upper age limit and 13 (8%) stop at 75 or younger; 31 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 9 · Phase 4 4
First in 1983; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Median enrollment 247 across the 42 interventional studies, 394 across the 43 observational. Of the 56 that completed or were terminated, 12 (21%) have results posted.
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43 of 85 have an industry lead sponsor. The 10 most frequent:
University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
University Hospital, Toulouse has 1 study filed under Arrhythmias, Cardiac — fewer than ten, so there is no comparison to draw.
5 of the studies in Arrhythmias, Cardiac with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04735016Medtronic Cardiac Ablation SolutionsDiamondTemp Global Registry | 2026-12-31 |
| NCT07118358Biotronik, Inc.BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System | 2027-03 |
| NCT06272396University Hospital, BordeauxRelevance of Recording an ECG Trace With a Connected Watch | 2027-03-26 |
| NCT06658899Cardurion Pharmaceuticals, Inc.A Phase 2 Study of CRD-4730 in CPVT | 2027-04 |
| NCT06083012Volta MedicalClinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation | 2027-04-27 |
Add all 5 to your calendar (.ics) → With an account.
Among the 85 studies in Arrhythmias, Cardiac with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: One year
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: One year
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2017 (actual). Primary completion is estimated for Jun 2019, 24 months after the start.
Of 189 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 140. This study's planned 24 months is below that.
Counting every sponsor, half of 258 studies reached it within 38 months; a quarter within 16 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse →