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

RECRUITINGN/ASponsored by Institut Mutualiste Montsouris
Actively Recruiting
PhaseN/A
SponsorInstitut Mutualiste Montsouris
Started2024-10
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06647251

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Atrial FibrillationHeart Disease

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