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AzTrials

Paroxysmal Atrial FibrillationCATS-AFNCT05565183

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

A study testing MRI (with injection of contrast product) in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
MRI (with injection of contrast product)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Oct 2022to Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Nicolas BADENCO, MD contact

+33 1 42 16 29 76

nicolas.badenco@aphp.fr

Zohra ABBOU contact

01 42 16 16 25 ext. +33

zohra.abbou@aphp.fr

France1 site

  • Institut de Cardiologie de la Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

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.

Read the 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.

Being tested
MRI (with injection of contrast product)
Keywords
Atrial Fibrillation, Atrial strain, High density electrical mapping, Catheter ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05565183
Study groupRoleWhat they receive
Patients with diagnosed Atrial fibrillation and an indication of catheter ablationExperimentalNot described
Receives: Diagnostic Test: MRI (with injection of contrast product)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 month

Secondary outcomes (21)

  1. 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

    Measured: 1 month

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

    Measured: 1 months

  3. Local atrial impedance measured by ablation catheter

    Measured: 1 months

  4. Contact force measured by ablation catheter

    Measured: 1 month

  5. Local impedance drop measured during radiofrequency delivery

    Measured: 1 month

  6. Duration of the ablation for each radiofrequency delivery

    Measured: 1 month

  7. Localization of the segmental and regional alteration of the myocardium in the left atrium measured during MRI

    Measured: 3 months

  8. Localization of zones with impaired 4D flow in the left atrium measured during MRI

    Measured: 3 months

  9. Left atrium volume (milliliter (mL)) measured during MRI

    Measured: 3 months

  10. Localization of areas of late enhancement in the left atrium

    Measured: 3 months

  11. Lesion transmurality performed by ablation in each segment of the pulmonary veins

    Measured: 3 months

  12. Subcutaneous measurement (AGE Reader) which combines aging and accumulation of glycated proteins in the subcutaneous tissue measured during MRI

    Measured: 3 months

  13. Volumes (milliliter (ml)) of the left atrium: in the basal state and after passive filling measured during echocardiography

    Measured: 1 month

  14. Analysis of the longitudinal deformation (strain) in speckle tracking in the basal state and after passive measured during echocardiography

    Measured: 1 month

  15. Absence of atrial fibrillation occurrence

    Measured: 12 months

  16. Absence of persistent atrial fibrillation occurrence

    Measured: 12 months

  17. Absence of atrial tachycardia or atrial flutter occurrence after catheter ablation

    Measured: 12 months

  18. Absence of palpitation occurrence after catheter ablation

    Measured: 12 months

  19. 6-minute walking test to assess exercise capacity

    Measured: 1 month

  20. 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

    Measured: 3 months

  21. 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565183
Sponsor's protocol ID
APHP190631
Acronym
CATS-AF
Status last verified
Aug 2022
First submitted
8 Aug 2022
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing MRI (with injection of contrast product) in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicolas BADENCO, MD (+33 1 42 16 29 76, nicolas.badenco@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05565183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

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