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NCT Number: NCT04229160

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation, Persistent Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caen University Hospital, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Previous atrial fibrillation ablation
  • Previous left atrial ablation or surgery
  • Atrial fibrillation without spontaneous RR interval > 1000ms and with LVEF < 35% (measured by TTE)
  • Presence of a mechanical mitral valve
  • Current intracardiac thrombus
  • Any condition contraindicating chronic anticoagulation
  • Uncontrolled hyperthyroidism
  • Anteroposterior LA diameter > 55 mm measured by TTE
  • Body mass index ≥ 40 kg/m2

Treatment and study plan

Noninvasive mapping (Cardioinsight® system)

Device

Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure

long-term cardiac monitoring (LINQ system)

Device

long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure

Atrial Fibrillation ablation procedure

Procedure

Atrial Fibrillation ablation procedure is done with standard practice

Primary outcomes

  1. Number of focal sources and rotors in atrial segments

    Time frame: within 1 hour post-cardioversion procedure

  2. Number of focal sources and rotors in atrial segments

    Time frame: within 1 hour post-Pulmonary Vein Isolation procedure

Secondary outcomes

  1. Number of Atrial Fibrillation recurrence following AF ablation procedure

    Time frame: 1 year post-procedure

  2. Number of success of Atrial Fibrillation induction after initial electrical cardioversion

    Time frame: within 2 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: CRYOVEST

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jan 18, 2020
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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