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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)

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ClinicalTrials.gov Identifier: NCT04229160
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation, Persistent Device: Noninvasive mapping (Cardioinsight® system) Device: long-term cardiac monitoring (LINQ system) Procedure: Atrial Fibrillation ablation procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229160


Contacts
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Contact: Frédéric ANSELME, Pr +3323288 ext 8116 frederic.anselme@chu-rouen.fr
Contact: Julien BLOT +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
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France
Caen University Hospital
Caen, France
Contact: Paul MILLIEZ, Pr         
Principal Investigator: Paul MILLIEZ, Pr         
Dieppe Hospital
Dieppe, France
Contact: Carole HUCHE, MD         
Principal Investigator: Carole HUCHE, MD         
Groupe Hospitalier du Havre
Le Havre, France
Contact: Nathanaël AUQUIER, MD         
Principal Investigator: Nathanaël AUQUIER, MD         
Rouen University Hospital
Rouen, France
Contact: Frédéric ANSELME, Pr         
Principal Investigator: Bénédicte GODIN, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Frédéric ANSELME, Pr Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04229160    
Other Study ID Numbers: 2018/418/HP
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
pulmonary vein isolation
cardioversion
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes