NL-OMON39773
Completed
Not Applicable
A prospective, randomized, multicenter, interventional study to evaluate the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation - Toccastar
St. Jude Medical GVA Sàrl0 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- atrial fibrillation
- Sponsor
- St. Jude Medical GVA Sàrl
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I\-IV antiarrhythmic drug
- •2\. Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device
- •3\. Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history
- •4\. Patient is 18 years of age or older
- •5\. Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits
- •6\. Patient provides written informed consent prior to enrollment in the study
Exclusion Criteria
- •1\. Persistent or long\-standing persistent atrial fibrillation (AF)
- •2\. Patient has had 4 or more cardioversions in the last 12 months
- •3\. Active systemic infection
- •4\. Presence of implantable cardiac defibrillator (ICD)
- •5\. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
- •6\. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
- •7\. Left atrial diameter \> 5\.0 cm
- •8\. Left ventricular ejection fraction \< 35%
- •9\. New York Heart Association (NYHA) class III or IV
- •10\. Previous left atrial ablation procedure, either surgical or catheter ablation
Outcomes
Primary Outcomes
Not specified
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