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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)

Primary Purpose

Atrial Fibrillation, Persistent

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Noninvasive mapping (Cardioinsight® system)
long-term cardiac monitoring (LINQ system)
Atrial Fibrillation ablation procedure
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation, Persistent focused on measuring pulmonary vein isolation, cardioversion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen University Hospital
  • Dieppe Hospital
  • Groupe Hospitalier du Havre
  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient with persistent atrial fibrillation

Arm Description

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

Outcomes

Primary Outcome Measures

Number of focal sources and rotors in atrial segments
Number of focal sources and rotors in atrial segments

Secondary Outcome Measures

Number of Atrial Fibrillation recurrence following AF ablation procedure
Number of success of Atrial Fibrillation induction after initial electrical cardioversion

Full Information

First Posted
January 9, 2020
Last Updated
June 24, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04229160
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent
Keywords
pulmonary vein isolation, cardioversion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient with persistent atrial fibrillation
Arm Type
Experimental
Arm Description
persistent atrial fibrillation is defined as lasting longer than 6 months documented by a 24h holter monitoring
Intervention Type
Device
Intervention Name(s)
Noninvasive mapping (Cardioinsight® system)
Intervention Description
Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure
Intervention Type
Device
Intervention Name(s)
long-term cardiac monitoring (LINQ system)
Intervention Description
long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure
Intervention Type
Procedure
Intervention Name(s)
Atrial Fibrillation ablation procedure
Intervention Description
Atrial Fibrillation ablation procedure is done with standard practice
Primary Outcome Measure Information:
Title
Number of focal sources and rotors in atrial segments
Time Frame
within 1 hour post-cardioversion procedure
Title
Number of focal sources and rotors in atrial segments
Time Frame
within 1 hour post-Pulmonary Vein Isolation procedure
Secondary Outcome Measure Information:
Title
Number of Atrial Fibrillation recurrence following AF ablation procedure
Time Frame
1 year post-procedure
Title
Number of success of Atrial Fibrillation induction after initial electrical cardioversion
Time Frame
within 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with documented persistent Atrial Fibrillation lasting longer than 6 months documented by 24h holter monitoring Age between 18 and 75 years Efficient oral anticoagulation during at least 1 month before the procedure Social security affiliation Feasible patient follow-up Patient willing to comply with study requirements and give informed consent to participate in this clinical study Indication for Pulmonary Vein isolation Exclusion Criteria: Previous atrial fibrillation ablation Previous left atrial ablation or surgery Atrial fibrillation without spontaneous RR interval > 1000ms and with LVEF < 35% (measured by TTE) Presence of a mechanical mitral valve Current intracardiac thrombus Any condition contraindicating chronic anticoagulation Uncontrolled hyperthyroidism Anteroposterior LA diameter > 55 mm measured by TTE Body mass index ≥ 40 kg/m2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric ANSELME, Pr
Phone
+3323288
Ext
8116
Email
frederic.anselme@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ANSELME, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul MILLIEZ, Pr
First Name & Middle Initial & Last Name & Degree
Paul MILLIEZ, Pr
Facility Name
Dieppe Hospital
City
Dieppe
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole HUCHE, MD
First Name & Middle Initial & Last Name & Degree
Carole HUCHE, MD
Facility Name
Groupe Hospitalier du Havre
City
Le Havre
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathanaël AUQUIER, MD
First Name & Middle Initial & Last Name & Degree
Nathanaël AUQUIER, MD
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric ANSELME, Pr
First Name & Middle Initial & Last Name & Degree
Bénédicte GODIN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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