An interventional study of Q-MODE : radiofrequency ablation up to 50W and Q-MODE+ : radiofrequency up to 90W in Atrial Fibrillation, sponsored by Institut Mutualiste Montsouris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Institut Mutualiste Montsouris · Not applicable, Interventional, and Treatment
Among 317 studies in Atrial Fibrillation with a site in France — 63 open to participants now, 87 under way, 5 of them phase 3. Atrial Fibrillation · France.
Among the 317 studies in Atrial Fibrillation with a site in France, this one is the 143rd largest by planned enrollment of the 193 interventional ones, is one of 15 that started in 2024, is one of 117 with no phase, reaches primary completion later than 51 of the 86 other live ones, and was the 282nd registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 90 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →63 of the 317 studies in Atrial Fibrillation with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →317 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 15 started in 2024.
Median enrollment 250 across the 193 interventional studies, 250 across the 123 observational. Of the 205 that completed or were terminated, 61 (30%) have results posted.
134 of 317 have an industry lead sponsor. The 10 most frequent:
Institut Mutualiste Montsouris is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Institut Mutualiste Montsouris has 2 studies filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
24 of the studies in Atrial Fibrillation with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT07633548University Hospital, CaenSafety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation | 2026-11-11 |
| NCT05773638University Hospital, BrestCardiovascular and Venous Thromboembolism Disease in Patients with Von Willebrand Disease in the French West | 2026-12-26 |
| NCT05777551Clinica MediterraneaAF Ablation With High Power Short Duration RF | 2026-12-31 |
| NCT05790707Poitiers University HospitalEfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment | 2027-01 |
Among the 317 studies in Atrial Fibrillation with a site in France, from their registry updates:
Pulmonary vein isolation is the main treatment of paroxysmal and persistent atrial fibrillation.
The aim of our study is to prospectively compare the efficacy and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions
Pulmonary vein isolation (PVI) is the main treatment of paroxysmal and persistant atrial fibrillation.
PVI is achieved by point-by-point radiofrequency ablation that creates flexible lesion set within targeted area.
PVI using standard ablation catheter with limited power (50W) have been described in case series with favorable efficacy and safety.
QDOTMicro™ is a radiofrequency ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.
QDOT Micro™ provides several options regarding radiofrequency administration :
Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).
Recently, preliminary animal data argue in favor or reducing the interpoint distance with QDOT™.
To date, there is no study comparing the 3 options of radiofrequency delivery. The aim of our study is to prospectively compare the efficacity and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions.
The same device is used in all three randomisation groups. The difference between the intervention is the intensity of the radiofrequency applied.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 50W.
Procedure: Q-MODE : radiofrequency ablation up to 50W
Radiofrequency ablation with High Power - Short Duration (HPSD) up to 90W.
Procedure: Q-MODE+ : radiofrequency up to 90W
A combination of the two ablation methods.
Procedure: Hybride Q-MODE/Q-MODE+: radiofrequency ablation up to 50W in the anterior part, and 90W in the posterior part
The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to Q-MODE option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 50W.
The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to Q-MODE+ option: the intensity of radiofrequency to isolate the pulmonary vein is limited to 90W.
The same device (QDOT Micro™) is used in all 3 arms of this trial. The 3 strategies of radiofrequency delivery within the 3 arms are already used in the standard of care. For patient randomized in this arm, the device is set to "Q-MODE/Q-MODE+" option: the intensity of radiofrequency delivered to isolate the pulmonary vein is limited to 50W in the anterior part and to 90W in the posterior part.
Incidence of primary adverse events related to the ablation procedure
Incidence of primary adverse events within 7 days after ablation in the 3 arms
Time frame: 7 days after ablation
Acute procedural success
Acute procedural success is defined as electrical isolation of all pulmonary veins
Time frame: At the end of the ablation procedure
Incidence of serious adverse event
Incidence of serious adverse events
Time frame: within 7 days (early onset), 7 to 30 days (periprocedural), up to 18 months (late onset) of the ablation procedure
Rate of additional lesions
Rate of additional lesions between all targeted veins and per subject
Time frame: At the end of the ablation procedure
Location of additional lesions
Anatomical location of additional lesions
Time frame: At the end of the ablation procedure
Use of another catheter
Use of another catheter than QDOT in all targeted veins
Time frame: At the end of the ablation procedure
Time spent in operating room
Time spent in operating room
Time frame: At the end of the ablation procedure
Skin-to-skin time
Skin-to-skin time
Time frame: At the end of the ablation procedure
Glove-to-glove time
Glove-to-glove time = total procedure time
Time frame: At the end of the ablation procedure
Mapping time
Mapping time
Time frame: At the end of the ablation procedure
Total ablation time
Total ablation time
Time frame: At the end of the ablation procedure
Left vein ablation time
Left vein ablation time
Time frame: At the end of the ablation procedure
Right vein ablation time
Right vein ablation time
Time frame: At the end of the ablation procedure
Number of radiofrequency applications
Number of radiofrequency applications
Time frame: At the end of the ablation procedure
Number of vHPSD radiofrequency applications
Number of vHPSD (very High Power Short Duration) radiofrequency applications
Time frame: At the end of the ablation procedure
Number of HPSD radiofrequency applications
Number of HPSD (High Power Short Duration) radiofrequency applications
Time frame: At the end of the ablation procedure
Temperature
Temperature
Time frame: At the end of the ablation procedure
Power
Power
Time frame: At the end of the ablation procedure
Contact force
Contact force
Time frame: At the end of the ablation procedure
Impedance
Impedance
Time frame: At the end of the ablation procedure
Start is estimated for Oct 2024; primary completion for Oct 2027, 36 months later.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 36 months is close to that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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Institut Mutualiste Montsouris