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

Atrial Fibrillation Clinical Trial

— QUAFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885883
• Other study ID #: 2011-A00285-36
• Secondary ID: 2011-04
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: December 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2016
• Est. primary completion date: December 19, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All persons > 18 years, which have:

gp paroxysmal or persistant FA

1. paroxysmal or persistent FA (under one year),

2. refractory to at least one antiarrhythmic drug therapy

3. eligible for an ablation procedure with cryotherapy

4. 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 .

Exclusion Criteria:

• 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)

• pregnant or nursing ( a pregnancy test must be performed for women of childbearing age at the time of inclusion , the result of this test will be communicated to them .

• the MRI examination takes place three months after the inclusion women of childbearing potential should be placed under effective contraception)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• MRI 3T

Locations

Country	Name	City	State
France	AP HM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantitative measure of atrial fibrosis		4 years