Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT06647251

Run by

Institut Mutualiste Montsouris

People needed

90

Starts

2024-10-01

Expected to finish

2028-10-01

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Institut Mutualiste Montsouris — Paris, Paris, France (enrolling)

Full record on ClinicalTrials.gov

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