N/A
Completed N=234
CARTO® 3 System and Real Time Intracardiac Ultrasound
Atrial Fibrillation · Paroxysmal AF
Source: ClinicalTrials.gov NCT01716663 ↗
Enrolled (actual)
234
Serious AEs
9.6%
Results posted
Dec 2014
Primary outcomePrimary: Total Fluoroscopy Time — 28.3 minutes
Summary
This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Fluoroscopy Time |
28.3 | — |
| SECONDARY Total Procedure Time |
150.2 | — |
| SECONDARY Acute Procedural Success |
226 | — |
| SECONDARY Mean Number of Radiofrequency (RF) Applications |
54.2 | — |
| SECONDARY Total Radiofrequency (RF) Time |
104.7 | — |
Eligibility Criteria
Inclusion Criteria
- Drug refractory, recurrent symptomatic paroxysmal AF
- Age 18 years or older
- Patients able and willing to provide written informed consent to participate in the study and comply with study requirements
Exclusion Criteria
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous ablation for atrial fibrillation
- AF episodes that last longer than 30 days
- Uncontrolled heart failure, or NYHA Class III or IV heart failure
- Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
- Contraindication to anticoagulation
- Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
- Awaiting cardiac transplantation
- Heart disease for which corrective surgery is anticipated within 6 months
- Enrollment in other investigational drug or device study
- Subjects unwilling to comply with protocol or follow-up requirements
- Patients who are pregnant
Data sourced from ClinicalTrials.gov (NCT01716663). 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.