Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation

NCT02885883 | Completed

• 2 other identifiers: 2011-A00285-362011-04
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Three groups of patients will be considered: a control group (n = 10); a group of patients with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will replace CT-scan usually performed in routine before the procedure (n = 15); a group of patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution 2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA relaxation times. Argus software will be used for post-treatment imaging. Quantitative data will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed between the three groups. Statistics will be performed with SPSS software in bilateral analysis and a value of p \< 0.05 will be considered as significant.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• quantitative measure of atrial fibrosis

  4 years

Study Arms (3)

a control group

ACTIVE COMPARATOR

Device: MRI 3T

patients with paroxysmal or persistent AF

EXPERIMENTAL

Device: MRI 3T

patients with permanent AF

EXPERIMENTAL

Device: MRI 3T

Interventions

MRI 3T DEVICE

a control group; patients with paroxysmal or persistent AF; patients with permanent AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All persons \> 18 years, which have:
• gp paroxysmal or persistant FA
• paroxysmal or persistent FA (under one year),
• refractory to at least one antiarrhythmic drug therapy
• eligible for an ablation procedure with cryotherapy
• the patient may benefit from surveillance. gp permanent FA permanent AF ( defined as chronic arrhythmia after 2 failed attempts to electrical cardioversion and / or more than one year old) , and hospitalized for cardiac reasons or not in different cardiology Timone .

You may not qualify if:

• age \< 18 years,
• cons -indications to MRI ( claustrophobia, pacemakers and implantable cardiac defibrillators , metal chips intra ocular , valvular mechanical prosthesis ) , allergy to gadolinium ,
• renal impairment ( creatinine clearance \<60 mL / min)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

AP HM

Marseille, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• catherine GEINDRE

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 1, 2016
• Study Start: July 1, 2011
• Primary Completion: December 19, 2015
• Study Completion: June 1, 2016
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

FR (1)