NCT06647251Recruiting
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal AF Ablation: a Prospective Study
Source: ClinicalTrials.gov · Last updated 17 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- Oct 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- Institut Mutualiste Montsouris
- Diseases
- Atrial fibrillation
- NCT number
- NCT06647251
What you commit to
- Study type: Interventional
- Planned participants: 90
- From Oct 2024 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- N/STEMI replacement or angioplasty or valve within 3 months prior to registration
Other illness
- History of atrial fibrillation ablation (surgery or catheter)
Other
- Documented left atrial thrombus
- Left atrial (LA) diameter \> 60mm / LA area \> 35cm2 / Left atrial volulme index (LAVI) \> 45ml/m2
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.