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 (CRYOVEST)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation, Persistent
• Intervention / Treatment: Device: Noninvasive mapping (Cardioinsight® system); Device: long-term cardiac monitoring (LINQ system); Procedure: Atrial Fibrillation ablation procedure

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric ANSELME, Pr; Phone Number: 8116 +3323288; Email: frederic.anselme@chu-rouen.fr

Study Locations

• France
  • Caen, France
    • Not yet recruiting
    • CAEN University Hospital
    • Contact: Paul MILLIEZ, Pr
    • Principal Investigator: Paul MILLIEZ, Pr
  • Dieppe, France
    • Not yet recruiting
    • Dieppe Hospital
    • Contact: Carole HUCHE, MD
    • Principal Investigator: Carole HUCHE, MD
  • Le Havre, France
    • Not yet recruiting
    • Groupe Hospitalier Du Havre
    • Contact: Nathanaël Auquier, MD
    • Principal Investigator: Nathanaël AUQUIER, MD
  • Rouen, France
    • Recruiting
    • ROUEN university hospital
    • Principal Investigator: Bénédicte GODIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patient with persistent atrial fibrillation; persistent atrial fibrillation is defined as lasting longer than 6 months documented by a 24h holter monitoring

Device: Noninvasive mapping (Cardioinsight® system); Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure; Device: long-term cardiac monitoring (LINQ system); long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure; Procedure: Atrial Fibrillation ablation procedure; Atrial Fibrillation ablation procedure is done with standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of focal sources and rotors in atrial segments	within 1 hour post-cardioversion procedure
Number of focal sources and rotors in atrial segments	within 1 hour post-Pulmonary Vein Isolation procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Atrial Fibrillation recurrence following AF ablation procedure	1 year post-procedure
Number of success of Atrial Fibrillation induction after initial electrical cardioversion	within 2 hours

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: cardioversion; pulmonary vein isolation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2018/418/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No