Comparing three methods of radiofrequency delivery for treating atrial fibrillation
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study
NA · Institut Mutualiste Montsouris · NCT06647251
This study is testing three different ways to use radiofrequency energy to treat people with paroxysmal atrial fibrillation to see which method works best and is safest.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Mutualiste Montsouris (other) |
| Locations | 1 site (Paris, Paris) |
| Trial ID | NCT06647251 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of three different radiofrequency delivery methods using the QDOT Micro™ catheter for patients with paroxysmal atrial fibrillation. The methods include Q-MODE, which delivers high power at a short duration, Q-MODE+ for very high power at very short duration, and a hybrid approach combining both methods. The study will systematically use catheter stabilization tools to ensure effective pulmonary vein isolation. By evaluating these methods, the study seeks to determine the best approach for achieving optimal treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over who are undergoing their first ablation for paroxysmal atrial fibrillation.
Not a fit: Patients with a history of atrial fibrillation ablation or significant left atrial enlargement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with atrial fibrillation, enhancing the efficacy and safety of ablation procedures.
How similar studies have performed: While small series have shown encouraging results with the QDOT Micro™ catheter, this study is novel as it is the first to compare the three radiofrequency delivery options directly.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 or over * First atrial fibrillation ablation * Paroxysmal atrial fibillation defined as atrial fibrillation lasting less than 48 hours * Early atrial fibrillation defined as atrial fibrillation lastiing between 7 days and 3 months * At least one episode of atrial fibrillation in the year preceding study entry * Patient affiliated to a health insurance Exclusion Criteria: * History of atrial fibrillation ablation (surgery or catheter) * Documented left atrial thrombus * Left atrial (LA) diameter \> 60mm / LA area \> 35cm2 / Left atrial volulme index (LAVI) \> 45ml/m2 * N/STEMI replacement or angioplasty or valve within 3 months prior to registration * Any contraindication mentioned in the instructions for use of the QDOT MICRO™ bidirectional navigation catheter * Patient unable to understand study information * Patient deprived of liberty by judicial or administrative decision
Where this trial is running
Paris, Paris
- Institut Mutualiste Montsouris — Paris, Paris, France (RECRUITING)
Study contacts
- Principal investigator: Frédéric SEBAG — Institut Mutualiste Montsouris
- Study coordinator: Naly ANDRIAMBAO
- Email: naly.andriambao@imm.fr
- Phone: +33156616439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation