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

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Completed

CT.gov ID

NCT02885883

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: MRI 3T	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Dec 19, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: a control group	Device: MRI 3T
Experimental: patients with paroxysmal or persistent AF	Device: MRI 3T
Experimental: patients with permanent AF	Device: MRI 3T

Arm

Intervention/Treatment

Active Comparator: a control group

Device: MRI 3T

Experimental: patients with paroxysmal or persistent AF

Device: MRI 3T

Experimental: patients with permanent AF

Device: MRI 3T

Outcome Measures

Primary Outcome Measures

quantitative measure of atrial fibrosis [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 .

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP HM	Marseille		France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: catherine GEINDRE, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT02885883

Other Study ID Numbers:

2011-A00285-36
2011-04

First Posted:

Sep 1, 2016

Last Update Posted:

Dec 13, 2018

Last Verified:

Dec 1, 2018

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Dec 13, 2018