Phase 4
Completed N=55
Ablation of the Pulmonary Veins for Paroxysmal Afib
Source: ClinicalTrials.gov NCT00744874 ↗Enrolled (actual)
55
Serious AEs
16.4%
Results posted
Jan 2013
Primary outcomePrimary: Number of Participants With Successful Pulmonary Vein Isolation — 53 participants
Summary
The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Pulmonary Vein Isolation |
53 | — |
| PRIMARY Chronic Effectiveness |
10 | — |
| PRIMARY Acute Safety |
2 | — |
| PRIMARY Chronic Safety |
— | — |
| SECONDARY Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months |
3.4; 1.9; 1.9; 3.2; 2; 1.9 | — |
| SECONDARY The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline |
46.4; 50.4; 51.8; 46.8; 49.4; 51.6 | — |
| SECONDARY Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins |
56.3 | — |
| SECONDARY Total Procedure Time |
117.9 | — |
| SECONDARY Total Fluoroscopy Time |
26 | — |
Eligibility Criteria
Inclusion Criteria
History of symptomatic paroxysmal atrial fibrillation defined as:
- Self terminating AF lasting no more than 7 days
- AF events demostrating spontaneous conversion back to sinus rhythm
- Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
- AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance
- Age between 18 and 70
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Exclusion Criteria
- Structural heart disease of clinical significance
- Prior ablation for arrhythmias other than AF within the past three months
- Prior left sided AF ablation
- Enrollment in any other ongoing arrhythmia study protocol
- Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
- Active infection or sepsis
- Any history of cerebral vascular disease including stroke or TIAs
- Pregnancy or lactation
- Untreatable allergy to contrast media
- Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
- History of blood clotting (bleeding or thrombotic) abnormalities
- Known sensitivities to heparin or warfarin
- Severe COPD (identified by an FEV1 < 1)
- Severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Data sourced from ClinicalTrials.gov (NCT00744874). 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.