Evaluation of Conventional Ablation With or Without Focal Impulse and Rotor Modulation to Eliminate Human AF (RECONFIRM)

This is an interventional treatment trial for Atrial Fibrillation focused on measuring rotor, FIRM, paroxysmal atrial fibrillation, persistent atrial fibrillation, atrial tachyarrhythmia, ablation, contact mapping, clinical trial, signal processing Read More

Inclusion Criteria:

1. Age >21 years
2. Reported incidence of at least two documented episodes of symptomatic paroxysmal or persistent atrial fibrillation (AF) during the 3 months preceding trial entry (at least one episode documented by 12-lead ECG or ECG rhythm strip). Ideally, patients will have implanted continuous ECG recorders in place for >30 days prior to the procedure to document AF episodes and percentage of time in AF ("burden") prior to ablation
3. Male -or- Women without childbearing potential (surgically sterile or have been without a period for 12 months), -or- Women of childbearing potential who are not pregnant per a serum HCG lab test
4. Refractory to at least one Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable
5. Willingness, ability and commitment to participate in baseline and follow-up evaluations without participation in another clinical trial (unless documented approval received from both sponsors)

6. Oral anticoagulation required for those subjects who have a score of two or more based on the following criteria (CHA2DS2VASc)

   • congestive heart failure (1 point)
   • hypertension (1 point)
   • age 75 years or older (2 points)
   • diabetes (1 point)
   • prior stroke or transient ischemic attack (2 points)
   • vascular disease (including coronary artery disease, CAD) (1 point)
   • age 65 years or older (1 point)
   • gender category: female (1 point) Pre-procedural anticoagulation will ideally have been continuous for 3 or more weeks prior to the procedure, as clinically indicated, with INR > 2 in patients taking warfarin.
7. Patient is willing and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects, and potentially indefinitely post procedure if the patient has CHA2DS2VASc score >or= 2
8. Signed, informed consent after a full discussion of the risks and benefits of both therapy arms, and the concept of randomization
9. NYHA Class 0, I or II and stable on medical therapy for > 3 months
10. Left atrial diameter <or= 5.5cm (CT or MRI preprocedure, or intracardiac echocardiography, with documented image of largest dimension)
11. LVEF >or= 40%
12. Sustained AF during procedure: If the patient does not experience spontaneous sustained AF (>10 min) during the procedure, typically in paroxysmal AF patients, sustained AF will be induced in routine fashion by burst pacing initially from the coronary sinus, then from other sites, then with isoproterenol infusion. Using intensive AF induction methods (Narayan, J Cardiovasc EP; 2012; 23(5): 447-454) sustained AF is induced in > 90% of paroxysmal AF patients presenting in sinus rhythm. If AF cannot be sustained, the patient does not meet the inclusion criteria for the protocol and the patient will undergo AF ablation per physician direction.

Exclusion Criteria:

1. Reversible Cause of Atrial Fibrillation: Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, pericarditis); Cardiac or thoracic surgery (e.g., valve repair or coronary artery bypass grafting, CABG) within the last 180 days; AF secondary to electrolyte imbalance, thyroid disease
2. Anti-Coagulation Contraindicated: Contraindication to Heparin; Contraindication to Warfarin or other novel oral anticoagulants (e.g., dabigatran, rivaroxabanm apixaban); History of significant bleeding abnormalities
3. Clotting Diathesis: History of significant blood clotting abnormalities, systemic thrombi or systemic embolization
4. Cardiac Prosthesis: ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve
5. Thrombus or Mass: Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) within 72 hours of the procedure; Intramural thrombus or other cardiac mass that may adversely affect catheter introduction or manipulation; Significant pulmonary embolus within 6 months of enrollment
6. Acute illness or active systemic infection or sepsis that may ordinarily warrant postponement of the procedure
7. History of recent cerebrovascular disease (stroke or TIA) or systemic thromboembolism within < 6 months
8. Severe Heart Failure: NYHA classes III, IV; Heart failure that is not stable on medical therapy; Pulmonary edema that may make planned anesthesia or sedation difficult
9. Non-Stable Coronary Disease: Stable/unstable angina or ongoing myocardial ischemia; Myocardial infarction (MI) within the past 3 months

10. Structural heart disease of clinical significance including:

    • Congenital heart disease where the abnormality or its correction prohibit or increase the risk of ablation
    • Acquired heart disease that may increase the risk of ablation, such as significant ventricular septal defect post myocardial infarction
    • Rheumatic valve disease, since this produces a unique AF phenotype
    • Extreme left atrial enlargement, defined as LA volume index > 60 ml/m2, in whom PVI has low success and 55 mm baskets are too small for the atria
11. Planned Cardiac Surgery: If cardiac transplantation or other cardiac surgery are planned within the 12 months follow period of the trial
12. Life expectancy less than 12 months (the followup period of the trial)
13. Significant pulmonary disease (e.g., COPD) or any other disease that significantly increase risk to the patient from sedation or anesthesia
14. Untreatable allergy to contrast media
15. Electrolyte imbalance: At the time of the ablation procedure, clinically significant abnormalities in serum potassium, sodium, magnesium or other electrolytes that affect the suitability of the patient for ablation at that time