Clinical trial NCT05565183: Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.
Official title: Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Catheter Ablation
Atrial Cardiomyopathy
Keywords: Atrial Fibrillation
Atrial strain
High density electrical mapping
Catheter ablation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Patient aged 18 to 60 years
2. Established diagnosis of paroxysmal or persistent symptomatic atrial fibrillation (AF) for at least 3 months with indication of catheter ablation
3. AF episode documented by ECG in the last 12 months
4. Structurally healthy heart, with an LVEF\> 50%, an interventricular septum \<12 mm and an OG volume \<40mL / m ² by TTE
5. Having given their informed consent in writing
6. Affiliated with or entitled to a French social security scheme

Exclusion Criteria:

1. Mitral valve disease with grade 2 to 4 insufficiency
2. Heart failure (NYHA stage II to IV in sinus rhythm and LVEF \< 50%), hypertrophic heart disease or congenital heart disease
3. Contraindication to oral anticoagulation
4. Intracardiac thrombus
5. History of ablation of the left atrium
6. History of heart surgery
7. 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)
8. History of myocardial infarction or coronary angioplasty within the last three months
9. Chronic obstructive pulmonary disease
10. Under guardianship or curatorship
11. Women who are pregnant, breastfeeding or of childbearing age in the absence of effective contraception
12. Participation in another interventional research involving a health product

Primary outcomes:
measure: Correlation between the regional and global longitudinal strain peaks (percent (%)) and voltage (millivoltage(mV)) of the left atrium measured by MRI and catheter ablation
timeFrame: 1 month
Secondary outcomes:
measure: 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
timeFrame: 1 month
measure: Localization in the left atrium and areas of fragmented atrial complexes measured during the ablation procedure
timeFrame: 1 months
measure: Local atrial impedance measured by ablation catheter
timeFrame: 1 months
measure: Contact force measured by ablation catheter
timeFrame: 1 month
measure: Local impedance drop measured during radiofrequency delivery
timeFrame: 1 month
measure: Duration of the ablation for each radiofrequency delivery
timeFrame: 1 month
measure: Localization of the segmental and regional alteration of the myocardium in the left atrium measured during MRI
timeFrame: 3 months
measure: Localization of zones with impaired 4D flow in the left atrium measured during MRI
timeFrame: 3 months
measure: Left atrium volume (milliliter (mL)) measured during MRI
timeFrame: 3 months
measure: Localization of areas of late enhancement in the left atrium
timeFrame: 3 months
measure: Lesion transmurality performed by ablation in each segment of the pulmonary veins
timeFrame: 3 months
measure: Subcutaneous measurement (AGE Reader) which combines aging and accumulation of glycated proteins in the subcutaneous tissue measured during MRI
timeFrame: 3 months
measure: Volumes (milliliter (ml)) of the left atrium: in the basal state and after passive filling measured during echocardiography
timeFrame: 1 month
measure: Analysis of the longitudinal deformation (strain) in speckle tracking in the basal state and after passive measured during echocardiography
timeFrame: 1 month
measure: Absence of atrial fibrillation occurrence
timeFrame: 12 months
measure: Absence of persistent atrial fibrillation occurrence
timeFrame: 12 months
measure: Absence of atrial tachycardia or atrial flutter occurrence after catheter ablation
timeFrame: 12 months
measure: Absence of palpitation occurrence after catheter ablation
timeFrame: 12 months
measure: 6-minute walking test to assess exercise capacity
timeFrame: 1 month
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut de Cardiologie de la Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas BADENCO, MD
role: PRINCIPAL_INVESTIGATOR
References: