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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01150214




Registration number
NCT01150214
Ethics application status
Date submitted
22/06/2010
Date registered
24/06/2010
Date last updated
2/06/2017

Titles & IDs
Public title
DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation
Scientific title
DECAAF: DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation
Secondary ID [1] 0 0
IRB_00039522
Universal Trial Number (UTN)
Trial acronym
DECAAF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - DE-MRI

DE-MRI - All patients will undergo Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI)to quantify the degree of atrial structural remodeling or fibrosis pre-ablation and DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify ablation-related scar formation.


Treatment: Surgery: DE-MRI
Using Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI) to identify fibrotic and scarred cardiac tissue. DE-MRI is a non-invasive method of identifying the extent and the distribution of structural remodeling or fibrosis and scarring associated with atrial fibrillation both pre- and post-ablation.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relationship between extent of pre-ablation fibrosis and recurrence post-ablation
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Relationship between extent of Post-ablation scar and incidence of atrial fibrillation recurrences post-catheter ablation for AF
Timepoint [1] 0 0
Post-ablation scar

Eligibility
Key inclusion criteria
* Patients who underwent an AF ablation as per recent Heart Rhythm Society (HRS) consensus document, as per the University of Utah AFIB Database (IRB_00020347)
* Patients who have had an MRI post-ablation.
* Age =18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent.
* Previous left atrial ablation or surgical procedure
* Renal failure with CrCl <60 ml/min
* Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
* Mental or physical inability to take part in the study
* Uncontrolled hypertension
* Morbid obesity (BMI > 35), or inability to be placed in MRI due to body mass.
* Patients who have not had a DE-MRI post-ablation.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
339
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Norwood
Recruitment postcode(s) [1] 0 0
5067 - Norwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
Belgium
State/province [6] 0 0
Ghent
Country [7] 0 0
France
State/province [7] 0 0
Bordeaux
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Nauheim
Country [9] 0 0
Germany
State/province [9] 0 0
Coburg
Country [10] 0 0
Germany
State/province [10] 0 0
Cologne
Country [11] 0 0
Germany
State/province [11] 0 0
Hamburg
Country [12] 0 0
Germany
State/province [12] 0 0
Leipzig
Country [13] 0 0
Netherlands
State/province [13] 0 0
Nieuwegein
Country [14] 0 0
Spain
State/province [14] 0 0
Catalonia

Funding & Sponsors
Primary sponsor type
Other
Name
University of Utah
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nassir F Marrouce, MD, FHRS
Address 0 0
CARMA Center, University of Utah
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01150214