Fact CheckerSign in

NCT04229160Completed

Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. AF ablation is a class IIa treatment for patients with symptomatic persistent AF refractory or intolerant to antiarrhythmic medication. There are still many debates considering the ablation strategy. The pulmonary veins remain the cornerstone of AF ablation therapy, even in persistent AF. There is a large electrical remodeling occurring in the left atrium between paroxysmal AF, early persistent AF and long-standing persistent AF. However, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources. Our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent AF \> 6 months pre- and post-cardioversion, and after pulmonary vein isolation.

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
9 Jan 2020
Start date
9 Jun 2020
Primary completion date
17 Jun 2026
Lead sponsor
University Hospital, Rouen
NCT number
NCT04229160

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 9 Jun 2020 to the primary completion date, 17 Jun 2026
  • 4 sites 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

  • Previous atrial fibrillation ablation
  • Previous left atrial ablation or surgery

Other illness

  • Any condition contraindicating chronic anticoagulation

Lab values

  • Atrial fibrillation without spontaneous RR interval \> 1000ms and with LVEF \< 35% (measured by TTE)

Other

  • Presence of a mechanical mitral valve
  • Current intracardiac thrombus
  • Uncontrolled hyperthyroidism
  • Anteroposterior LA diameter \> 55 mm measured by TTE
  • Body mass index ≥ 40 kg/m2

Who the study is looking for

  • Patients with documented persistent Atrial Fibrillation lasting longer than 6 months documented by 24h holter monitoring
  • Age between 18 and 75 years
  • Efficient oral anticoagulation during at least 1 month before the procedure
  • Social security affiliation
  • Feasible patient follow-up
  • Patient willing to comply with study requirements and give informed consent to participate in this clinical study
  • Indication for Pulmonary Vein isolation

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Caen University Hospital
Coordinator of this site? Confirm its status
CaenFranceUnknown status
Dieppe Hospital
Coordinator of this site? Confirm its status
DieppeFranceUnknown status
Groupe Hospitalier du Havre
Coordinator of this site? Confirm its status
Le HavreFranceUnknown status
Rouen University Hospital
Coordinator of this site? Confirm its status
RouenFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.