Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology I… (NCT04740801) | Clinical Trial Compass
CompletedNot Applicable
Electrical Coupling Information From The RHYTHMIA HDx Mapping System and DIRECTSENSE Technology In The Treatment of Paroxysmal Atrial Fibrillation (LOCALIZE CF)
The objective of this study is to evaluate whether local impedance (DIRECTSENSEâ„¢) drop on the INTELLANAV STABLEPOINTâ„¢ ablation catheter is associated with late pulmonary vein (PV) reconnections and durable conduction block in patients undergoing de novo PV isolation (PVI) for treatment of paroxysmal atrial fibrillation (PAF).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. History of recurrent, symptomatic, paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation (AF) that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes at least one AF episode electrocardiographically documented and at least one additional symptomatic recurrence with or without electrocardiographic documentation, within 365 days prior to enrollment.
✓. Subjects who are eligible for an ablation procedure for paroxysmal AF according to international and local guidelines on catheter ablation of AF.
✓. Subjects refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker, class I or III antiarrhythmic medication taken for the treatment of AF/AT (Atrial Tachycardia)/AFL (Atrial Flutter) or contraindicated to any class I or III antiarrhythmic medications, Beta Blocker or Calcium Channel Blocker.
✓. Subjects who are willing and capable of providing informed consent.
✓. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center.
✓. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to local and national law.
Exclusion criteria
✕. Any known contraindication to an AF ablation or anticoagulation
✕. Continuous AF lasting longer than seven days from onset (no episodes within 365 days from enrollment)
✕. History of previous LA ablation or surgical treatment for AF/AT/AFL
What they're measuring
1
Association between Local Impedance drop values and PV reconnections