Back to resultsCombined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation. (CATS-AF)
Primary Purpose
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Catheter Ablation
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI (with injection of contrast product)
Sponsored by
About this trial
This is an interventional prevention trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial Fibrillation, Atrial strain, High density electrical mapping, Catheter ablation
Eligibility Criteria
Inclusion Criteria:
- Patient aged 18 to 60 years
- Established diagnosis of paroxysmal or persistent symptomatic atrial fibrillation (AF) for at least 3 months with indication of catheter ablation
- AF episode documented by ECG in the last 12 months
- Structurally healthy heart, with an LVEF> 50%, an interventricular septum <12 mm and an OG volume <40mL / m ² by TTE
- Having given their informed consent in writing
- Affiliated with or entitled to a French social security scheme
Exclusion Criteria:
- Mitral valve disease with grade 2 to 4 insufficiency
- Heart failure (NYHA stage II to IV in sinus rhythm and LVEF < 50%), hypertrophic heart disease or congenital heart disease
- Contraindication to oral anticoagulation
- Intracardiac thrombus
- History of ablation of the left atrium
- History of heart surgery
- Contraindication to performing MRI or using the DOTAREM™ contrast medium (pacemaker, defibrillator, prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, treatment type endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic medical device or equipment, kidney disease with GFR < 30 mL/min, hypersensitivity to gadoteric acid or to excipients)
- History of myocardial infarction or coronary angioplasty within the last three months
- Chronic obstructive pulmonary disease
- Under guardianship or curatorship
- Women who are pregnant, breastfeeding or of childbearing age in the absence of effective contraception
- Participation in another interventional research involving a health product
Sites / Locations
- Institut de Cardiologie de la Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with diagnosed Atrial fibrillation and an indication of catheter ablation
Arm Description
Outcomes
Primary Outcome Measures
Correlation between the regional and global longitudinal strain peaks (percent (%)) and voltage (millivoltage(mV)) of the left atrium measured by MRI and catheter ablation
Secondary Outcome Measures
Localization in the left atrium and area of low amplitude electrogram areas (<0.5 mV, <0.3 mV and <0.1 mV) measured during the ablation procedure
Localization in the left atrium and areas of fragmented atrial complexes measured during the ablation procedure
Local atrial impedance measured by ablation catheter
Contact force measured by ablation catheter
Local impedance drop measured during radiofrequency delivery
Duration of the ablation for each radiofrequency delivery
Localization of the segmental and regional alteration of the myocardium in the left atrium measured during MRI
Localization of zones with impaired 4D flow in the left atrium measured during MRI
Left atrium volume (milliliter (mL)) measured during MRI
Localization of areas of late enhancement in the left atrium
Lesion transmurality performed by ablation in each segment of the pulmonary veins
Subcutaneous measurement (AGE Reader) which combines aging and accumulation of glycated proteins in the subcutaneous tissue measured during MRI
Volumes (milliliter (ml)) of the left atrium: in the basal state and after passive filling measured during echocardiography
Analysis of the longitudinal deformation (strain) in speckle tracking in the basal state and after passive measured during echocardiography
Absence of atrial fibrillation occurrence
Absence of persistent atrial fibrillation occurrence
Absence of atrial tachycardia or atrial flutter occurrence after catheter ablation
Absence of palpitation occurrence after catheter ablation
6-minute walking test to assess exercise capacity
Differences in the volumes (milliliter (ml)) of the left atrium (maximum, minimum, atrial pre-systole) between the segmentation performed manually and the segmentation obtained by learning transfer
Distance between areas of low voltages identified by the cartography and areas of late 3D enhancement identified by MRI, measurement based on the volume (milliliter (ml)) resulting from CT-scan and MRI fusion
Full Information
NCT ID
NCT05565183
First Posted
August 8, 2022
Last Updated
October 3, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05565183
Brief Title
Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.
Acronym
CATS-AF
Official Title
Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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 The treatment of atrial fibrillation (AF) includes 2 axes: the prevention of the cardio-embolic risk and rhythm control. The possibilities for this control are antiarrhythmic drugs and, above all, catheter ablation, an interventional cardiology technique which consists in treating the areas responsible for the initiation and perpetuation of AF by applying radiofrequency energy or cryotherapy to the myocardial tissue.
Limited research has been done on the combination of different parameters to manage AF, especially during the initial stage of the disease. A translational and multimodal approach could make it possible to better characterize this pathology and thus, help to adjust the therapeutic management for the patients.
The combined analysis of regional electrophysiological, morphological, and functional parameters of the left atrium could make it possible to better detect early atrial cardiomyopathy and predict recurrences of atrial fibrillation.
Detailed Description
The electrophysiological substrate for patients with persistent atrial fibrillation is heterogeneous with areas of atrial myocardium of low voltage amplitudes and areas of rapid fragmented signals in arrhythmia. The targets of ablation treatment in these cases are currently poorly defined. Several promising strategies have emerged, such as the isolation of fibrotic areas, low voltage.
An integration analysis of regional electrophysiological, morphological, and functional parameters of the left atrium, therefore, open up a new area of research that has not been studied to date and could help to better guide the therapeutic management of patients with AF.
The study aims to assess the association between regional and global myocardial strain abnormalities on magnetic resonance imaging (MRI) and the amplitude of the atrial intracardiac electrical potential, in young subjects with symptomatic AF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Catheter Ablation, Atrial Cardiomyopathy
Keywords
Atrial Fibrillation, Atrial strain, High density electrical mapping, Catheter ablation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with diagnosed Atrial fibrillation and an indication of catheter ablation
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI (with injection of contrast product)
Intervention Description
All patients included in the study will undergo two MRI examinations (with injection of contrast product) before and after the ablation procedure.
Primary Outcome Measure Information:
Title
Correlation between the regional and global longitudinal strain peaks (percent (%)) and voltage (millivoltage(mV)) of the left atrium measured by MRI and catheter ablation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Localization in the left atrium and area of low amplitude electrogram areas (<0.5 mV, <0.3 mV and <0.1 mV) measured during the ablation procedure
Time Frame
1 month
Title
Localization in the left atrium and areas of fragmented atrial complexes measured during the ablation procedure
Time Frame
1 months
Title
Local atrial impedance measured by ablation catheter
Time Frame
1 months
Title
Contact force measured by ablation catheter
Time Frame
1 month
Title
Local impedance drop measured during radiofrequency delivery
Time Frame
1 month
Title
Duration of the ablation for each radiofrequency delivery
Time Frame
1 month
Title
Localization of the segmental and regional alteration of the myocardium in the left atrium measured during MRI
Time Frame
3 months
Title
Localization of zones with impaired 4D flow in the left atrium measured during MRI
Time Frame
3 months
Title
Left atrium volume (milliliter (mL)) measured during MRI
Time Frame
3 months
Title
Localization of areas of late enhancement in the left atrium
Time Frame
3 months
Title
Lesion transmurality performed by ablation in each segment of the pulmonary veins
Time Frame
3 months
Title
Subcutaneous measurement (AGE Reader) which combines aging and accumulation of glycated proteins in the subcutaneous tissue measured during MRI
Time Frame
3 months
Title
Volumes (milliliter (ml)) of the left atrium: in the basal state and after passive filling measured during echocardiography
Time Frame
1 month
Title
Analysis of the longitudinal deformation (strain) in speckle tracking in the basal state and after passive measured during echocardiography
Time Frame
1 month
Title
Absence of atrial fibrillation occurrence
Time Frame
12 months
Title
Absence of persistent atrial fibrillation occurrence
Time Frame
12 months
Title
Absence of atrial tachycardia or atrial flutter occurrence after catheter ablation
Time Frame
12 months
Title
Absence of palpitation occurrence after catheter ablation
Time Frame
12 months
Title
6-minute walking test to assess exercise capacity
Time Frame
1 month
Title
Differences in the volumes (milliliter (ml)) of the left atrium (maximum, minimum, atrial pre-systole) between the segmentation performed manually and the segmentation obtained by learning transfer
Time Frame
3 months
Title
Distance between areas of low voltages identified by the cartography and areas of late 3D enhancement identified by MRI, measurement based on the volume (milliliter (ml)) resulting from CT-scan and MRI fusion
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 18 to 60 years
Established diagnosis of paroxysmal or persistent symptomatic atrial fibrillation (AF) for at least 3 months with indication of catheter ablation
AF episode documented by ECG in the last 12 months
Structurally healthy heart, with an LVEF> 50%, an interventricular septum <12 mm and an OG volume <40mL / m ² by TTE
Having given their informed consent in writing
Affiliated with or entitled to a French social security scheme
Exclusion Criteria:
Mitral valve disease with grade 2 to 4 insufficiency
Heart failure (NYHA stage II to IV in sinus rhythm and LVEF < 50%), hypertrophic heart disease or congenital heart disease
Contraindication to oral anticoagulation
Intracardiac thrombus
History of ablation of the left atrium
History of heart surgery
Contraindication to performing MRI or using the DOTAREM™ contrast medium (pacemaker, defibrillator, prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, treatment type endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic medical device or equipment, kidney disease with GFR < 30 mL/min, hypersensitivity to gadoteric acid or to excipients)
History of myocardial infarction or coronary angioplasty within the last three months
Chronic obstructive pulmonary disease
Under guardianship or curatorship
Women who are pregnant, breastfeeding or of childbearing age in the absence of effective contraception
Participation in another interventional research involving a health product
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas BADENCO, MD
Phone
+33 1 42 16 29 76
Email
nicolas.badenco@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Zohra ABBOU
Phone
01 42 16 16 25
Ext
+33
Email
zohra.abbou@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas BADENCO, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cardiologie de la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
IPD Sharing Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal
Learn more about this trial
Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.
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