---
title: 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
nct_id: NCT04229160
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: University Hospital, Rouen
study_type: INTERVENTIONAL
primary_condition: Atrial Fibrillation, Persistent
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04229160.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04229160"
ct_last_update_post_date: 2025-09-17
last_seen_at: "2026-05-12T06:09:47.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04229160](https://clinicaltrials.gov/study/NCT04229160)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** University Hospital, Rouen
- **Conditions:** Atrial Fibrillation, Persistent
- **Start Date:** 2020-06-09
- **Completion Date:** 2026-06-24
- **CT.gov Last Update:** 2025-09-17

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **patient with persistent atrial fibrillation** (EXPERIMENTAL) — persistent atrial fibrillation is defined as lasting longer than 6 months documented by a 24h holter monitoring

## Interventions

- **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

- **Number of focal sources and rotors in atrial segments** _(time frame: within 1 hour post-cardioversion procedure)_
- **Number of focal sources and rotors in atrial segments** _(time frame: within 1 hour post-Pulmonary Vein Isolation procedure)_

## Secondary Outcomes

- **Number of Atrial Fibrillation recurrence following AF ablation procedure** _(time frame: 1 year post-procedure)_
- **Number of success of Atrial Fibrillation induction after initial electrical cardioversion** _(time frame: within 2 hours)_

## Locations (4)

- Caen University Hospital, Caen, France
- Dieppe Hospital, Dieppe, France
- Groupe Hospitalier du Havre, Le Havre, France
- Rouen University Hospital, Rouen, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.caen university hospital|caen||france` — added _(2026-05-12)_
- `locations.dieppe hospital|dieppe||france` — added _(2026-05-12)_
- `locations.groupe hospitalier du havre|le havre||france` — added _(2026-05-12)_
- `locations.rouen university hospital|rouen||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04229160.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04229160*  
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