The Substrate and Intervention Mechanisms for Persistent Atrial Fibrillation Trial (SIMPle-AF)
Persistent Atrial Fibrillation
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial Fibrillation, Atrial Fibrosis, Late Gadolinium Enhancement Magnetic Resonance Imaging, Computational Modeling, Rotor Anchor Sites
Eligibility Criteria
Inclusion Criteria:
- History of persistent atrial fibrillation
- Indicated for an AF-ablation procedure
- Agree to participate in the trial
Exclusion Criteria:
- Are unable or unwilling to provide informed consent for the SIMPle AF study
- Patients with cardiac devices like pacemakers, internal cardiac defibrillators and Cardiac Resynchronization Therapy Device (CRT). Patients with acute or chronic renal insufficiency (glomerular filtration rate <30 ml/min/1.73 m2), or patients in the perioperative liver transplantation period
- Pregnant women
- Patients who are unable to adhere to the follow up protocol
- Patients with contraindication to MRI, including ferromagnetic aneurysm clips, metal in the eye, and implanted ferromagnetic or other MRI-incompatible devices
- Patients in whom the LGE Cardiac MRI does not meet quality standards for fibrosis analysis
- Subjects without daily access to a smart phone or tablet compatible with the mobile-based application and ability to upload ECG tracings for the follow up period
Patients with a history of allergic reactions to gadolinium-based contrast agents or ingredients and will not be premedicated**
- Subjects with a history of reaction to contrast may be premedicated according to institutional protocol prior to receiving intravenous contrast agents
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Conventional PVI
PVI + Scar-based ablation
PVI + Modeling-predicted rotors ablation
Conventional PVI by Radio-frequency Ablation: Wide area circumferential pulmonary vein isolation (PVI) only (current standard of care) using radio-frequency ablation catheters.
Scar-Based Radio-frequency Ablation: Pulmonary vein isolation followed by targeting, using radio-frequency ablation, of dense LGE sites on MRI, which are confirmed on bipolar mapping to have voltage <0.3 mV.
Rotor Anchors Radio-frequency Ablation: Pulmonary vein isolation followed by radio-frequency ablation of rotor anchors predicted by modeling.