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

Paroxysmal Atrial Fibrillation Clinical Trial

— CATS-AF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05565183
• Other study ID #: APHP190631
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: November 2025

Study information

• Verified date: August 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nicolas BADENCO, MD
• Phone: +33 1 42 16 29 76
• Email: nicolas.badenco[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Catheter Ablation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Diagnostic Test:
• MRI (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.

Locations

Country	Name	City	State
France	Institut de Cardiologie de la Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the regional and global longitudinal strain peaks (percent (%)) and voltage (millivoltage(mV)) of the left atrium measured by MRI and catheter ablation		1 month
Secondary	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		1 month
Secondary	Localization in the left atrium and areas of fragmented atrial complexes measured during the ablation procedure		1 months
Secondary	Local atrial impedance measured by ablation catheter		1 months
Secondary	Contact force measured by ablation catheter		1 month
Secondary	Local impedance drop measured during radiofrequency delivery		1 month
Secondary	Duration of the ablation for each radiofrequency delivery		1 month
Secondary	Localization of the segmental and regional alteration of the myocardium in the left atrium measured during MRI		3 months
Secondary	Localization of zones with impaired 4D flow in the left atrium measured during MRI		3 months
Secondary	Left atrium volume (milliliter (mL)) measured during MRI		3 months
Secondary	Localization of areas of late enhancement in the left atrium		3 months
Secondary	Lesion transmurality performed by ablation in each segment of the pulmonary veins		3 months
Secondary	Subcutaneous measurement (AGE Reader) which combines aging and accumulation of glycated proteins in the subcutaneous tissue measured during MRI		3 months
Secondary	Volumes (milliliter (ml)) of the left atrium: in the basal state and after passive filling measured during echocardiography		1 month
Secondary	Analysis of the longitudinal deformation (strain) in speckle tracking in the basal state and after passive measured during echocardiography		1 month
Secondary	Absence of atrial fibrillation occurrence		12 months
Secondary	Absence of persistent atrial fibrillation occurrence		12 months
Secondary	Absence of atrial tachycardia or atrial flutter occurrence after catheter ablation		12 months
Secondary	Absence of palpitation occurrence after catheter ablation		12 months
Secondary	6-minute walking test to assess exercise capacity		1 month
Secondary	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		3 months
Secondary	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		3 months