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, Persistent Clinical Trial

— CRYOVEST  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04229160
• Other study ID #: 2018/418/HP
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: June 2023

Study information

• Verified date: January 2020
• Source: University Hospital, Rouen
• Contact: Frédéric ANSELME, Pr
• Phone: +3323288
• Email: frederic.anselme[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	Dieppe Hospital	Dieppe
France	Groupe Hospitalier du Havre	Le Havre
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of focal sources and rotors in atrial segments		within 1 hour post-cardioversion procedure
Primary	Number of focal sources and rotors in atrial segments		within 1 hour post-Pulmonary Vein Isolation procedure
Secondary	Number of Atrial Fibrillation recurrence following AF ablation procedure		1 year post-procedure
Secondary	Number of success of Atrial Fibrillation induction after initial electrical cardioversion		within 2 hours