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

NCT05565183 | Unknown

• 1 other identifier: APHP190631
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Catheter Ablation; Atrial Cardiomyopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• 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

• Localization in the left atrium and areas of fragmented atrial complexes measured during the ablation procedure

  1 months

• Local atrial impedance measured by ablation catheter

  1 months

• Contact force measured by ablation catheter

  1 month

• Local impedance drop measured during radiofrequency delivery

  1 month

Study Arms (1)

Patients with diagnosed Atrial fibrillation and an indication of catheter ablation

EXPERIMENTAL

Diagnostic Test: MRI (with injection of contrast product)

Interventions

MRI (with injection of contrast product) DIAGNOSTIC_TEST

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

Patients with diagnosed Atrial fibrillation and an indication of catheter ablation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Institut de Cardiologie de la Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nicolas BADENCO, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas BADENCO, MD

CONTACT

+33 1 42 16 29 76; nicolas.badenco@aphp.fr

Zohra ABBOU

CONTACT

01 42 16 16 25; zohra.abbou@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: October 4, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

FR (1)