N/A
Completed N=511
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
Atrial Fibrillation · Paroxysmal Arrhythmia
Source: ClinicalTrials.gov NCT01585961 ↗
Enrolled (actual)
511
Serious AEs
12.4%
Results posted
Jan 2015
Primary outcomePrimary: Total Fluoroscopy Time — 26.4 minutes
Summary
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Fluoroscopy Time |
26.4 | — |
| PRIMARY Total Procedure Time |
169.8 | — |
| PRIMARY Acute Procedural Success |
488 | — |
| SECONDARY Mean Number of Radiofrequency (RF) Applications |
45.0 | — |
| SECONDARY Total Radiofrequency (RF) Time |
57.9 | — |
| SECONDARY Fluid Volume Delivered Via Ablation Catheter |
974.2 | — |
| SECONDARY Number of Patients With Repeat Ablations |
74 | — |
| SECONDARY Post-procedure AF Symptoms |
155 | — |
| SECONDARY Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit |
20 | — |
| SECONDARY Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation |
73 | — |
| SECONDARY Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation |
56 | — |
| SECONDARY Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score |
36.0 | — |
Eligibility Criteria
Inclusion Criteria
- Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
- Age 18 years or older
- Patients must be able and willing to provide written informed consent to participate in the study
Exclusion Criteria
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for atrial fibrillation
- Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
- Uncontrolled heart failure, or NYHA Class III or IV heart failure
- Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
- Contraindication to anticoagulation
- Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
- Awaiting cardiac transplantation
- Heart disease in which corrective surgery is anticipated within 6 months
- Enrollment in investigational drug, biologic or device study
- Subjects unwilling to comply with protocol or follow-up requirements
- Patients who are pregnant
Data sourced from ClinicalTrials.gov (NCT01585961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.