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Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.

Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05565183
Acronym
CATS-AF
Enrollment
60
Registered
2022-10-04
Start date
2022-10-31
Completion date
2025-11-30
Last updated
2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Cardiomyopathy, Catheter Ablation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation, Atrial strain, High density electrical mapping, Catheter ablation

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.

Interventions

DIAGNOSTIC_TESTMRI (with injection of contrast product)

All patients included in the study will undergo two MRI examinations (with injection of contrast product) before and after the ablation procedure.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Correlation between the regional and global longitudinal strain peaks (percent (%)) and voltage (millivoltage(mV)) of the left atrium measured by MRI and catheter ablation1 month

Secondary

MeasureTime frame
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 procedure1 month
Localization in the left atrium and areas of fragmented atrial complexes measured during the ablation procedure1 months
Local atrial impedance measured by ablation catheter1 months
Contact force measured by ablation catheter1 month
Local impedance drop measured during radiofrequency delivery1 month
Duration of the ablation for each radiofrequency delivery1 month
Localization of the segmental and regional alteration of the myocardium in the left atrium measured during MRI3 months
Localization of zones with impaired 4D flow in the left atrium measured during MRI3 months
Left atrium volume (milliliter (mL)) measured during MRI3 months
Localization of areas of late enhancement in the left atrium3 months
6-minute walking test to assess exercise capacity1 month
Subcutaneous measurement (AGE Reader) which combines aging and accumulation of glycated proteins in the subcutaneous tissue measured during MRI3 months
Volumes (milliliter (ml)) of the left atrium: in the basal state and after passive filling measured during echocardiography1 month
Analysis of the longitudinal deformation (strain) in speckle tracking in the basal state and after passive measured during echocardiography1 month
Absence of atrial fibrillation occurrence12 months
Absence of persistent atrial fibrillation occurrence12 months
Absence of atrial tachycardia or atrial flutter occurrence after catheter ablation12 months
Absence of palpitation occurrence after catheter ablation12 months
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 transfer3 months
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 fusion3 months
Lesion transmurality performed by ablation in each segment of the pulmonary veins3 months

Countries

France

Contacts

Primary ContactNicolas BADENCO, MD
nicolas.badenco@aphp.fr+33 1 42 16 29 76
Backup ContactZohra ABBOU
zohra.abbou@aphp.fr01 42 16 16 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026