N/A
Completed N=119
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
Source: ClinicalTrials.gov NCT00584415 ↗Enrolled (actual)
119
Serious AEs
8.4%
Results posted
Jul 2014
Primary outcomePrimary: Atrial Tachyarrhythmia Recurrence in Participants — 37 participants
Summary
The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrial Tachyarrhythmia Recurrence in Participants |
37 | — |
| SECONDARY Total Number of Significant Ablation Procedure Related Complications |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater or equal to 18 years
- At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
- Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
- Informed consent obtained.
Exclusion Criteria
- Left atrial thrombus
- Acute myocardial infarction within eight (8) weeks
- Atriotomy within eight (8) weeks
- Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
- Pregnancy
- Ablation in a pulmonary vein within 4 months.
- Occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
- Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
- Enrolled in an investigational study evaluating another device or drug
- Unwilling to participate in the study or unavailable for follow-up visits.
- Incarcerated
Data sourced from ClinicalTrials.gov (NCT00584415). 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.