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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2026-06-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Noninvasive Mapping Before Surgical Ablation

NCT06803615

Atrial Fibrillation (AF)

ACTIVE_NOT_RECRUITING

Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation

NCT04045067

Cardiovascular Diseases Atrial Fibrillation, Persistent

COMPLETED

Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months

NCT00259623

Atrial Fibrillation

COMPLETED NA

Efficacy of Different Ablation Strategies for Controlling Atrial Fibrillation

NCT00379301

Atrial Fibrillation

COMPLETED NA

Analysis of Endocavitary Electrical Signal and Surface Electrocardiogram to Predict Ablation Outcome in Persistent Atrial Fibrillation

NCT03937089

Atrial Fibrillation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation, Persistent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient with persistent atrial fibrillation

persistent atrial fibrillation is defined as lasting longer than 6 months documented by a 24h holter monitoring

Group Type EXPERIMENTAL

Noninvasive mapping (Cardioinsight® system)

Intervention Type DEVICE

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

long-term cardiac monitoring (LINQ system)

Intervention Type DEVICE

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

Atrial Fibrillation ablation procedure

Intervention Type PROCEDURE

Atrial Fibrillation ablation procedure is done with standard practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Noninvasive mapping (Cardioinsight® system)

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

Intervention Type DEVICE

long-term cardiac monitoring (LINQ system)

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

Intervention Type DEVICE

Atrial Fibrillation ablation procedure

Atrial Fibrillation ablation procedure is done with standard practice

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No