Back to resultsNon-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation (QUAFI)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI 3T
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
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)
Sites / Locations
- AP HM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
a control group
patients with paroxysmal or persistent AF
patients with permanent AF
Arm Description
Outcomes
Primary Outcome Measures
quantitative measure of atrial fibrosis
Secondary Outcome Measures
Full Information
NCT ID
NCT02885883
First Posted
August 23, 2016
Last Updated
December 11, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02885883
Brief Title
Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
Acronym
QUAFI
Official Title
Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 19, 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a control group
Arm Type
Active Comparator
Arm Title
patients with paroxysmal or persistent AF
Arm Type
Experimental
Arm Title
patients with permanent AF
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI 3T
Primary Outcome Measure Information:
Title
quantitative measure of atrial fibrosis
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
catherine GEINDRE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
AP HM
City
Marseille
Country
France
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
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