The goal of this study is to determine the long term success of non-paroxysmal ablation to treat atrial fibrillation using three different approaches: specified low voltage-directed with pulmonary vein isolation, empiric posterior wall isolation with pulmonary vein isolation and an approach of pulmonary vein isolation (PVI) alone. During the trial, patients will be monitored with implantable loop recorders and attend a follow-up appointment one year after participating in the trial.
303 subjects will be enrolled in the study. The primary purpose of the trial is treatment. The study began on February 14, 2017 and is estimated to be completed by January 2021.
- Non-Paroxysmal Atrial Fibrillation.
- Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
- 18-85 year of age at the time of consent.
- Able and willing to comply with all protocol visit requirements.
- Signed Patient Informed Consent (ICF).
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
- Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included.
- Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
- Ejection Fraction < 0.20.
- Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
- Left atrial size > 60 mm diameter on echocardiogram.
- “Long standing” persistent AF defined as > or = 1 year of continuous atrial fibrillation at the time of enrollment.
- Severe pulmonary hypertension (PAP > 70 mmHg)
- AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
- Poor candidate for general anesthesia.
- Anticipated survival < 1 year.
- MI or CABG within 3 months.
- Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
- Any documented thromboembolic event within 6 months of the ablation procedure.
- Contraindication to anticoagulation.
- Inability to have implantable monitoring devices for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias.
- Significant congenital anomaly or medical condition that may affect the integrity of study data.
- Women who are pregnant – pregnancy test required if pre-menopausal or non-sterile.
- Active enrollment in another investigational study involving a drug or device.
- Inability to undergo complete voltage mapping in normal sinus rhythm – see intraprocedural protocol.
The study will take place at the MetroHealth Medical Center, Cleveland, Ohio, United States, 44109. If you have any questions, please contact Peter Leo BS, RN at 216-778-2714 / firstname.lastname@example.org.
Sponsors / Collaborators
This study is sponsored by Ohad Ziv and Biosense Webster, Inc. The principal investigator is Ohad Ziv, MD of the MetroHealth System.
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