Evaluation of Conventional Ablation With or Without Focal Impulse and Rotor Modulation to Elimina… (NCT02456233) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Conventional Ablation With or Without Focal Impulse and Rotor Modulation to Eliminate Human AF
United States84 participantsStarted 2016-04
Plain-language summary
This prospective randomized study will assess the safety and efficacy of FIRM-guided ablation (FIRM+PVI) compared to pulmonary vein isolation (PVI) without FIRM, for the treatment of symptomatic atrial fibrillation.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Age \>21 years
✓. 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
✓. 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
✓. Refractory to at least one Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable
✓. 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)
✓. Oral anticoagulation required for those subjects who have a score of two or more based on the following criteria (CHA2DS2VASc)
✓. 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
✓. Signed, informed consent after a full discussion of the risks and benefits of both therapy arms, and the concept of randomization
Exclusion criteria
✕. 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
✕. Anti-Coagulation Contraindicated: Contraindication to Heparin; Contraindication to Warfarin or other novel oral anticoagulants (e.g., dabigatran, rivaroxabanm apixaban); History of significant bleeding abnormalities
✕. Clotting Diathesis: History of significant blood clotting abnormalities, systemic thrombi or systemic embolization
✕. 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
✕. Acute illness or active systemic infection or sepsis that may ordinarily warrant postponement of the procedure
✕. History of recent cerebrovascular disease (stroke or TIA) or systemic thromboembolism within \< 6 months
✕. 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