DECAAF: Delayed-Enhancement MRI (DE-MRI) Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— DECAAF  

Official title:

DECAAF: DE-MRI Determinant of Successful Radiofrequency Catheter Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150214
• Other study ID #: IRB_00039522
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: June 1, 2017
• Start date: July 2010
• Est. completion date: September 2012

Study information

• Verified date: June 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Atrial fibrillation (AF) is an electrophysiological condition characterized by a disorganized electrical activity in the atria of the heart. AF is associated with structural heart disease including hypertension, systolic and diastolic ventricular dysfunction and valvular heart disease. It represents a significant public health problem with the increasing longevity of the general population. A major determinant of the progression of AF is structural remodeling or fibrosis that occurs in the left atrium. A more extensively remodeled atrium represents the substrate needed for the arrhythmia to persist. Structural remodeling is also a major determinant for success of rhythm control strategies in AF. While catheter ablation has been reproducibly shown to be superior to anti-arrhythmic drug therapy for rhythm control in AF, the success of this procedure is significantly affected by the extent of structural remodeling present at the time of catheter ablation.

Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI) has been demonstrated to be a very effective modality in identifying fibrotic and scarred cardiac tissue with excellent correlation with autopsy findings. This is related to the characteristics of Gadolinium, an extracellular contrast agent that is very effective in identifying regions of fibrotic non-viable myocardium. DE-MRI technology can be a very powerful, non-invasive method, of identifying the extent and the distribution of structural remodeling or fibrosis associated with AF.

Applying DE-MRI technology to the atrium causes significant technical challenges. The atrial wall is often a few millimeters thick which requires high spatial resolution to obtain adequate and useful images. In addition, image acquisition has to be gated to the diastolic phase of the atrial contraction cycle, which may be difficult to do when the patient is in AF. The ongoing research at the University of Utah has shown significant progress and very promising results overcoming the challenges mentioned. Specific image acquisition sequences have allowed for reproducible identification of high pixel intensity regions within the 2-dimensional images of the atrial wall. Three-dimensional reconstruction of the entire left atrium then provides a quantification of the overall volume occupied by these hyper-enhanced regions relative to the entire left atrial wall volume. Used prior to catheter ablation, DE-MRI can therefore identify regions of significant structural remodeling or fibrosis. The same technology has also been shown to be very useful in examining the amount and distribution of ablation related scarring.

Clinical patient characteristics will be collected for this study from clinic visits and chart reviews.

Imaging Protocol: All patients will undergo a DE-MRI within 30 days prior to the AF ablation procedure using a DE-MRI protocol. 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 (Figs. 4-5).

Clinical Follow-up: The institution where the ablation was performed will continue post-procedural care following standard of care procedures. Monitoring and definition of atrial arrhythmia AF recurrences will be guided by the HRS consensus document on ablation of atrial fibrillation.

Clinical and MRI data will be stored using the IRB-approved University of Utah database. De-identified clinical data and MRI images from participating institutions will also be submitted to the database, and will be processed at the University of Utah for pre- and post-ablation fibrosis and scar quantification. The ablation strategy utilized and procedural endpoint will be left to the discretion of the operators at the participating sites. This data will also be collected and included in the final analysis. MRI image processors at the University of Utah will be blinded to the ablation technique and mother institution using a unique de-identified study participant ID number.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Norwood	South Australia
Belgium	Universitair Ziekenhuis Ghent	Ghent
France	Hôpital Cardiologique du Haut-Lévêque/Bordeaux	Bordeaux
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Coburg Klinik	Coburg
Germany	Institut für Diagnostische und Interventionelle Radiologie - koln	Cologne
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitatsklinikum Leipzig	Leipzig
Netherlands	St Antonius Ziekenhuis Hospital	Nieuwegein
Spain	Hospital Clinic de Barcelona	Barcelona	Catalonia
United States	Loyola University Medical Center	Chicago	Illinois
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Sarah Cannon Research Institute (Centennial)	Nashville	Tennessee
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Florida Heart Rhythm Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Netherlands,  Spain, 

References & Publications (4)

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. Erratum in: Europace. 2009 Jan;11(1):132. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between extent of pre-ablation fibrosis and recurrence post-ablation	The percentage of pre-ablation fibrosis in atrial fibrillation patients can significantly impact the incidence of recurrences post-ablation.	1 year
Secondary	Relationship between extent of Post-ablation scar and incidence of atrial fibrillation recurrences post-catheter ablation for AF	The extent of lesions created by ablation may have an impact on the incidence of recurrence of AF post-ablation	Post-ablation scar

External Links

•   DECAAF Website