1. David J Wilber MD Loyola University Chicago
DECAAF II UPDATE
David J Wilber MD
Loyola University Chicago
Disclosures: Abbott: Investigator. ACCF: Consultant. Biosense / Webster: Consultant, Investigator; Medtronic: Consultant, Investigator

2. DECAAF I: MRI IN PREDICTING ABLATION OUTCOME
Baseline Scan
Marrouche et al,
JAMA 2014.
311(5):

3. IS FIBROSIS AN ABLATION TARGET?
Retrospective analysis of DECAAF data
Age yrs, 64% PAF
Baseline fibrosis quantified in 273 of 330 pts (83%)
Post ablation fibrosis quantified in 177 pts
1 year recurrence in 36%
Multivariate predictors
Baseline fibrosis (p<0.001)
adjusted HR 1.089
( )
Residual fibrosis (p<0.001)
adjusted HR 1.09 (1.054-
1.126)
PVI not a predictor
Akoum et al, JCE 2015; 26:

4. ATRIAL MYOPATHY? DE-MRI Prediction of Ablation Outcomes
Mild Moderate Extensive
<15% (N=43) % (N=30) >35% (N=8)
81 pts (50% PAF)
Moderate/extensive enhancement more frequent in persistent AF (70% vs 32%)
Extent of DE strongest predictor of recurrence in multivariate analysis, LA volume and persistent AF weaker predictors
Oakes et al, Circulation 2009; 119:

5. DECAAF II
Prospective RCT of PVI + Fibrosis guided ablation vs PVI alone
Inclusion:
persistent AF (> 7 days),
first AF ablation,
age > 18 yrs
Exclusion:
contraindication or inability to obtain acceptable quality MRI
No access or ability for daily ECG upload via smart phone or tablet
Prior valve surgery
Power and sample size
517 arrhythmia recurrence events
90% power to detect a 25% reduction in recurrence (2 sided α 0.05)
888 pts assuming 60% 1 year recurrence in conventional treatment group
DSMB conducts interim analysis after 1/3 and 2/3 of total projected events with Obrien-Fleming boundaries to guide early termination.

6. DECAAF II ENDPOINTS Primary efficacy endpoint:
any nonself-terminating episode of atrial tachyarrhyhmia (AF, flutter, AT) demonstrated by at least 2 consecutive valid ECG tracings within 6 hours to a maximum of 7 days, after 3 mo blanking period
Secondary efficacy endpoint:
Quality of Life (Toronto AFSS, SF-36) 3 and 12 mo
Primary Safety Endpoint:
composite of stroke, PV stenosis, bleeding, heart failure, death
Data Coordinating Center: CARMA

7. DECAAF DESIGN MRI-fibrosis images not made available
Images made available to site clinician

8. Group 1--PVI

9. Group 2—Targeting fibrosis

10. Targeting Fibrosis

11. DECAAF WORKFLOW

12. Progress To Date Planned enrollment: 900 pts
1st Subject Enrolled: July 2016
660 pts randomized as of Feb 13, 2019
43 Activated Trial Sites US
Europe 22
Australia 4 -
Would also like to mention the study is being diligently monitored by the Data Monitoring Committee who have performed quarterly safety reviews with full endorsement of the continuation of the trial w/o modification.

13. QUESTIONS?