Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
This is a multi-center, observational, 1-year prospective cohort study (1 year follow-up, at
3, 6 and 12 month) with approximately 675 participants. We will conduct a thorough outcomes
assessment utilizing data from Magnetic Resonance Imaging (MRI) scans, as well as
pre-procedure and follow-up data. Scans will be blinded to location of participating site.
MRI scans will be sequenced and analyzed as they arrive from the database.

Imaging Protocol: All patients will undergo a Delayed-Enhancement MRI (DE-MRI) within 30 days
prior to the atrial fibrillation (AF) ablation procedure. The purpose of the initial MRI is
to quantify the degree of atrial structural remodeling or fibrosis pre-ablation. Following
ablation, DE-MRI will be obtained at 3, 6, and 12 months follow-up to detect and quantify
ablation-related scar formation.

Clinical Follow-up: The institution where the ablation was performed will continue
post-procedural care following standard of care procedures.

Atrial arrhythmia recurrences will be catalogued up to one year post-ablation and predictors
of recurrences of AF will be determined by statistical analysis. The specific mechanism and
electrophysiological characteristics of atrial arrhythmia recurrence will also be analyzed.

Our hypotheses are (1) DE-MRI will reproducibly stage the progression left atrium fibrosis in
AF; (2) DE-MRI will reproducibly aid in quantifying and identifying the distribution of
catheter ablation-related scarring in the left atrium; and (3) the stage of left atrium
fibrosis pre-ablation and the amount and location of scarring will predict success of
catheter ablation therapy for AF.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01150214
Trial related presentations / publications
Oakes RS, Badger TJ, Kholmovski EG, Akoum N, Burgon NS, Fish EN, Blauer JJ, Rao SN, DiBella EV, Segerson NM, Daccarett M, Windfelder J, McGann CJ, Parker D, MacLeod RS, Marrouche NF. Detection and quantification of left atrial structural remodeling with delayed-enhancement magnetic resonance imaging in patients with atrial fibrillation. Circulation. 2009 Apr 7;119(13):1758-67. doi: 10.1161/CIRCULATIONAHA.108.811877. Epub 2009 Mar 23.
McGann CJ, Kholmovski EG, Oakes RS, Blauer JJ, Daccarett M, Segerson N, Airey KJ, Akoum N, Fish E, Badger TJ, DiBella EV, Parker D, MacLeod RS, Marrouche NF. New magnetic resonance imaging-based method for defining the extent of left atrial wall injury after the ablation of atrial fibrillation. J Am Coll Cardiol. 2008 Oct 7;52(15):1263-71. doi: 10.1016/j.jacc.2008.05.062.
Segerson NM, Daccarett M, Badger TJ, Shabaan A, Akoum N, Fish EN, Rao S, Burgon NS, Adjei-Poku Y, Kholmovski E, Vijayakumar S, DiBella EV, MacLeod RS, Marrouche NF. Magnetic resonance imaging-confirmed ablative debulking of the left atrial posterior wall and septum for treatment of persistent atrial fibrillation: rationale and initial experience. J Cardiovasc Electrophysiol. 2010 Feb;21(2):126-32. doi: 10.1111/j.1540-8167.2009.01611.x. Epub 2009 Oct 5.
Calkins H, Brugada J, Packer DL, Cappato R, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, Haines DE, Haissaguerre M, Iesaka Y, Jackman W, Jais P, Kottkamp H, Kuck KH, Lindsay BD, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Natale A, Pappone C, Prystowsky E, Raviele A, Ruskin JN, Shemin RJ; Heart Rhythm Society; European Heart Rhythm Association; European Cardiac Arrhythmia Society; American College of Cardiology; American Heart Association; Society of Thoracic Surgeons. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. A report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership with the European Heart Rhythm Association (EHRA) and the European Cardiac Arrhythmia Society (ECAS); in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Endorsed and approved by the governing bodies of the American College of Cardiology, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, and the Heart Rhythm Society. Europace. 2007 Jun;9(6):335-79. doi: 10.1093/europace/eum120. No abstract available. Erratum In: Europace. 2009 Jan;11(1):132.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01150214